Summary of EMDN 2025 Submissions and outcome of annual revision

MDCG 2026-1

EMDN UPDATE SUBMISSIONS FROM 2025

PUBLIC CONSULTATION AND THE MDCG

NOMENCLATURE WORKING GROUP

OUTCOME OF THE ANALYSIS OF SUBMISSIONS

1. ACCEPTED

2. PARTIALLY ACCEPTED

E.g. the request for a new code is accepted but not in the level proposed by the submitter.

3. NOT ACCEPTED

E.g.

✓ request not integrated/integrated with no sufficient information/technical details for the technical

evaluation; ✓ request to insert an existing level;

✓ request to insert a new level/edit an existing level not compliant with the nomenclature structure.

1. Not accepted submissions from 2025 public

consultation and the MDCG Nomenclature working

group

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT A0199 NEEDLES -

OTHER

"Filtered Venting Needles (sterile) and Chemo-Vent Needles (sterile) are used to vent evacuated containers and to maintain the necessary sterility. Aspirating Needles (sterile) are used to allow the withdrawal of fluids for all mini vials and deep containers“ Request not integrated/integrated with no sufficient information/technical details.

INSERT

A99 - DEVICES FOR

ADMINISTRATION, WITHDRAWAL AND

COLLECTION - OTHER

"Aspirating Needles (sterile) are used to allow the withdrawal of fluids for all mini vials and deep containers. Filtered Venting Needles (sterile) and Chemo-Vent Needles (sterile) are used to vent evacuated containers and to maintain the necessary sterility.“ Request not integrated/integrated with no sufficient information/technical details.

UPDATE

A99 - DEVICES FOR

ADMINISTRATION, WITHDRAWAL AND

COLLECTION - OTHER

"Filtered Venting Needles (sterile) and Chemo-Vent Needles (sterile) are used to vent evacuated containers and to maintain the necessary sterility. Aspirating Needles (sterile) are used to allow the withdrawal of fluids for all mini vials and deep containers." Request not integrated/integrated with no sufficient information/technical details.

UPDATE V - VARIOUS MEDICAL

DEVICES labeling Request not integrated/integrated with no sufficient information/technical details.

UPDATE

Q0199 -

ODONTOLOGY

DEVICES - OTHER

Because I am not sure whether our company had an EMDN or not before. Request not integrated/integrated with no sufficient information/technical details.

MOVING

V9099 VARIOUS

DEVICES NOT

INCLUDED IN OTHER

CLASSES - OTHER

The intended purpose of the Light Handles is to extend the sterile barrier to manipulate overhead operating room (OR) lights and are used in combination with Universal Light Adapters. The Light Sleeves are intended as a disposable barrier to extend the sterile barrier to manipulate overhead operating room (OR) lights and are used in combination with Universal Light Handles. Request not integrated/integrated with no sufficient information/technical details.

OUTCOME: NOT ACCEPTED-INSUFFICIENT INFORMATION

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

UPDATE

V0380 - DEVICES WITH

MEASURING FUNCTIONS -

ACCESSORIES

CONTAINER WITH MEASURING FUNCTION

Request not integrated/integrated with no sufficient information/technical details.

INSERT

Z12011305 - SMALL LOAD

AUTOCLAVES WITH A

CHAMBER SMALLER THAN 1

STANDARD STERILISATION

UNIT x cx xc Request not integrated/integrated with no sufficient information/technical details.

INSERT W01 – REAGENTS

These instruments can be used to examine urine and other body fluids for human cells, other microscopic structures, and organisms. These instruments have controls and calibrators which are used to ensure that the instruments are providing the correct cell/sediment counts. At this time there are no categories for these device types or for the instruments. The microscopy instruments can be used either alone to provide counts of the sample structures of interest or in a workcell with chemistry analyzerssuch that counts and chemistry results can be obtained for the same samples. The intended use of the instruments contains the following language (see attached file containing the IFU cover page and intended use): “The instrument produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms." Request not integrated/integrated with no sufficient information/technical details.

INSERT W02-IVD INSTRUMENTS

These instruments that can be used to examine urine and other body fluids for human cells, other microscopic structures, and organisms. At this time there are no categories for these device types or for the instruments, there are options for general laboratory microscopes, but since the devices are automated, use controls/calibrators, and have associated reagents that are used with the samples, the general microscope terms do not represent their intended use. The microscopy instruments can be used either alone to provide automated counts of the sample structures of interest or in a workcell with chemistry analyzerssuch that counts and chemistry results can be obtained for the same samples. The intended use of the instruments contains the following language (see attached file containing the IFU cover page and intended use): "The instrument produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms." Request not integrated/integrated with no sufficient information/technical details.

OUTCOME: NOT ACCEPTED-INSUFFICIENT INFORMATION

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT Y2145-HEARING AIDS

"Justification for the New EMDN Code: Almost all available hearing aids require software for proper configuration, including fitting software for professionals and user applications for customization and control. Without these solutions, hearing aids cannot be tailored to individual audiological needs, which is essential for optimal outcomes. Currently, the EMDN classification system only covers hardware-based hearing aids and accessories. Existing categories like ""Hearing Aids – Other"" and ""Accessories"" are too generic and fail to address essential software solutions. While other EMDN sub-groups have dedicated software codes, and the MDA system classifies standalone medical device software under MDA 0315, hearing aid software still lacks a specific EMDN code. This gap risks inaccurate classification and regulatory ambiguity despite the critical role of software in fitting, customization, and remote care. Scope of the Proposed Code: The proposed EMDN code ""Hearing Aid

• - Software"" is intended to cover all types of software that directly interact with hearing aids for the purpose of configuration, control, or communication. This includes, but is not limited to: 1.Fitting Software: Used by qualified hearing care professionals to program, configure, and fine-tune hearing aids; Ensures that hearing aids are adapted to the patient’s specific hearing loss and preferences; Critical for the initial setup and ongoing adjustment of hearing aids.

1. 2. User Applications: Allow hearing aid users to adjust settings (e.g., volume, sound profiles) within predefined limits set by the fitting software; Provide features such as connectivity with mobile devices and remote communication with hearing care professionals for adjustments; Empower users to personalize their hearing aids and improve their overall experience;
2. 3. Remote Care and Monitoring Software: Enables remote fitting and fine-tuning of hearing aids by hearing care professionals; Facilitates follow-up care and maintenance without the need for in-person visits, improving accessibility for patients." Request not integrated/integrated with no sufficient information/technical details.

OUTCOME: NOT ACCEPTED-INSUFFICIENT INFORMATION

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT

V08 - Medical disposable bedding (non-sterile) The disposable patient bedding set is intended for short-term single use in healthcare facilities, such as hospitals, ambulances, patient transport and nursing homes, and home care, and provides a physical barrier against the direct transmission of potentially contaminated germs to the patient. A disposable patient bedding set is an assortment of bedding that includes a sheet, pillow and pillowcase, and blanket and blanket cover, all typically made of one or more thin nonwoven fabrics or textile laminates. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to T030502 BED AND STRETCHER

HYGIENIC COVERS)

UPDATE

A080101 - ENTERAL

FEEDING BAGS AND

CONTAINERS, INCLUDE A BAG

AND/OR A SPIKE TO

CONNECT TO A

PREFILLED

CONTAINER

(INCLUDING THOSE

VIA PUMP), SINGLE-

USE Enteral feeding sets not only include specifications that contain bags, but also specifications that contain spikes (used to connect to other containers), but because of the description "ENTERAL FEEDING BAGS AND CONTAINERS", it is difficult for NB, consultants, and manufacturers to determine whether this EMDN code includes the specification of spike type. Moreover, there is no other EMDN code in this library that is more suitable for the description of enteral feeding sets, so the relevant terminology should be added to make the description clearer. The editing of an existing term is aimed at making it more comprehensive, clearer, or to remove any errors; the request is for devices that can be included in A030403

ENTERAL NUTRITION KITS (INCLUDING THOSE VIA

PUMP), SINGLE USE

MOVING

CATEGORY Y -

DEVICES FOR

PERSONS WITH

DISABILITIES NOT

INCLUDED IN OTHER

CATEGORIES

Implementation of a different subdivision of the existing groups (2ndlevels), in order to be aligned with the current version of ISO 9999 and reallocationof related bottom levels from the 3rdto the terminal level The update resulting from the alignment to ISO 9999 (v. 2022) is not feasible due to the impact on the current structure. The estimated impact of the proposal is to reallocate (deletion+insert) about 250 codes, including more than 190 terminal ones.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT T0307 - Patient fixation device The device is designed to provide protection to the upper and lower extremities of patients and allows to secure them to their bed or chair. A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)]

INSERT

Z12030380-Enteral Feeding Pumps- Accessories The enteral feeding pump Backpack is designed to carry either the Enteral Feeding Pump, disposable feeding sets, and accessories to facilitate enteral feeding and/or flushing while ambulatory. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to Z12030380 INFUSION

INSTRUMENTS - HARDWARE ACCESSORIES)

INSERT

Z120880: Obstetrics and Gynaecology Instruments- Accessories Buttonhole Belts are used to hold an ultrasound transducer and a tocodynamometer and/or other accessories in place on a pregnant woman’s abdomen during situations where the monitoring of fetal heartrate and uterine contractions is indicated. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to Z12080180 PRENATAL

DIAGNOSTIC INSTRUMENTS-HARDWARE

ACCESSORIES

UPDATE

W0201020201 -

IMMUNOCHEMISTR

Y READERS

“Dear responsible party, Our organization, acting as a notified body, seeks clarification regarding the versioning of this EMDN database. We've observed a discrepancy: the exported Excel list is dated September 29, 2021, with revision 1.1, while the webpage indicates Version 1.4. Furthermore, it seems unlikely that no updates have been made since 2021. Could you please explain how this database is managed and when we can expect to see information about any changes? Thank you in advance for your assistance.” Request for general clarification on EMDN

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

MOVING

A060102 SURGICAL

DRAINAGE

CONNECTION

MEDICAL TUBES

Bubble Tubing is used as a conduit to aspirate, remove or sample body fluids by connecting various devices to an external vacuum source. Connectors are used to connect two or more separate lengths of tubing. The level is not intended for connectors, but for medical tubes designed to join elements of surgical drainage systems; therefore, moving it to the section dedicated to connectors is not considered appropriate.

INSERT

K01010106

ABDOMINAL TROCAR, SINGLE-USE

Intended to establish a path of entry for minimally invasive instruments. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to the level K01010101-TROCAR STANDARD, SINGLE-USE).

INSERT

K01020207 ROBOTIC

SURGERY TROCAR

ACCESSORIES, SINGLE-USE

Trocars and accessories are intended to establish a path of entry to the body cavity to perform laparoscopic and robotic surgery. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to K01010180 TROCAR, SINGLE-USE –

ACCESSORIES)

Introducing a level for accessories exclusively for robotic trocars would imply the need to consider adding detailed levels for all trocar types within the section.

INSERT M030507

Support Boards I.V. Baby Support Boards immobilize and hold steady patient’s limbs when securing I.V. lines, thus potentially preventing unwanted movement of limbs and kinking or dislodgement of I.V. catheters. I.V. Baby Support Boards (“Baby Boards”) are a product family that comprises single use, disposable, devices used in the care of infants. The baby boards are used to immobilize and hold infants’ limbs when securing I.V. lines. They are CE marked for sale globally and manufactured at the Gananoque manufacturing facility. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN [refer to V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)]

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

UPDATE P090804050202 METAL FEMORAL HEADS, TOTAL HIP

REPLACEMENT

P090804050202 = TÊTE FÉMORALE MÉTALLIQUE POUR

PROTHÈSE TOTALE

This refers to a femoral head with a small non-anatomical diameter (e.g., 28 mm) intended to articulate with a prosthetic component (an acetabular component in the case of a total prosthesis or a mobile cup in the case of a partial prosthesis). Better distinction from P090804050102. The editing of an existing term is aimed at making it more comprehensive, clearer, or to remove any errors.

UPDATE P090804050102 METAL FEMORAL HEADS, PARTIAL HIP

REPLACEMENT

P090804050102 = TÊTE FÉMORALE MÉTALLIQUE POUR

PROTHÈSE PARTIELLE

This refers to a femoral head with an anatomical diameter (e.g.,

50 mm) intended to articulate with an anatomical acetabulum

(in the case of a partial prosthesis). Better distinction from P090804050202] The editing of an existing term is aimed at making it more comprehensive, clearer, or to remove any errors. UPDATE Z120622-MUSCLE STIMULATORS There is no specific code for TENS device The editing of an existing term is aimed at making it more comprehensive, clearer, or to remove any errors. For the device in question please refer to Z120601 ELECTROTHERAPY

EQUIPMENT (INCLUDED TENS)

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT P09098006 - KNEE PROSTHESES

STEMS

Our modular total knee revision system includes stems which can be used as tibial stem or as femoral stem. We are currently forced to choose one of the two codes P0909800601 or P0909800602 while this is not fully correct. By choosing the code for tibial stem, we would exclude the use as femoral stem and vice versa. Therefore, we are requesting to add a code which represents the dual use of the knee prosthesis stems. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN. If necessary, multiple codes can be assigned to the same UDI-DI.

UPDATE/DELETE

• P0908040501 FEMORAL HEADS

FOR PRIMARY IMPLANT OF

PARTIAL PROSTHESES;

• P0908040502 FEMORAL HEADS

FOR PRIMARY IMPLANT OF TOTAL

PROSTHESES;

• P090804050299 FEMORAL HEADS

FOR PRIMARY IMPLANT OF TOTAL

PROSTHESES – OTHER;

• • P0908040504 Revision femoral heads; Proposed edit to terms for specific levels (P0908040501, P0908040502, and P090804050299) to include components for revision procedures. Consequently, dedicated revision level P09080405 will be deleted. Certain adapters function as spare parts in revision operations when combined with compatible heads, aiming to preserve existing anchored stems or total endoprostheses. A specific adapter type can also be used in primary operations for positioning correction with approved stems. The adapter/head system is thus applicable in both primary and revision surgeries. Current head codes (P09080405) necessitate a choice between primary and revision categories, which is not currently feasible for the system. The editing of an existing term is aimed at making it more comprehensive, clearer, or to remove any errors. If necessary, multiple codes can be assigned to the same UDI-DI.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT

V9099 - VARIOUS DEVICES NOT

INCLUDED IN OTHER CLASSES -

OTHER

Skin Cleansing Alcohol Prep is used for cleansing skin prior to injection EMDN refers to the classification of medical devices and in vitro diagnostic devices as defined in Regulations EU 2017/745 and 2017/746 or products without a medical intended purpose as defined in Regulations EU 2017/745 Annex XVI.

INSERT Z1302 - DIAGNOSTIC REGISTRATION

PAPERS

Prescription assistance software program is currently Legacy Device (MDD). It has been under directive since May 14, 2020. Applicable classification rule and paragraph: Rule 11. Designation codes concerned by the request (Regulation 2017/2185): MDA - 0315 and MDT – 2011 and 2012. EMDN refers to the classification of medical devices and in vitro diagnostic devices as defined in Regulations EU 2017/745 and 2017/746 or products without a medical intended purpose as defined in Regulations EU 2017/745 Annex XVI. INSERT A11-SAMPLE COLLECTION SWABS Robotic swab collector from the oral cavity and oropharynx The device that is currently still under development EMDN refers to the classification of medical devices and in vitro diagnostic devices as defined in Regulations EU 2017/745 and 2017/746 or products without a medical intended purpose as defined in Regulations EU 2017/745 Annex XVI The device in question is not placed on the EU market and there is no confirmation of the start of the conformity assessment.

INSERT Q0299 - OPHTHALMIC DEVICES -

OTHER

Thyroid Eye Disease (TED) Activity Assessment Software. The device is undergoing the conformity assessment and there is no devices with the same intended use on the EU market. Temporarily not accepted.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONALE

INSERT J0301 - COCHLEAR IMPLANTABLE

DEVICES Cochlear Implantable Devices with drug eluting electrode. EMDN refers to the classification of medical devices and in vitro diagnostic devices as defined in Regulations EU 2017/745 and 2017/746 or products without a medical intended purpose as defined in Regulations EU 2017/745 Annex XVI The device is in a preliminary stage prior to starting the conformity assessment.

INSERT

J0303 - PROFOUND DEAFNESS

BRAINSTEM ACTIVE-IMPLANTABLE

DEVICES

Cochlear Implantable Devices with implantable battery and microphone. EMDN refers to the classification of medical devices and in vitro diagnostic devices as defined in Regulations EU 2017/745 and 2017/746 or products without a medical intended purpose as defined in Regulations EU 2017/745 Annex XVI The device is in a preliminary stage prior to starting the conformity assessment.

INSERT J03 - AUDITORY ACTIVE-

IMPLANTABLE DEVICES

Cochlear Implantable Devices with drug eluting electrode and implantable battery and microphone. EMDN refers to the classification of medical devices and in vitro diagnostic devices as defined in Regulations EU 2017/745 and 2017/746 or products without a medical intended purpose as defined in Regulations EU 2017/745 Annex XVI The device is in a preliminary stage prior to starting the conformity assessment.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

2. Accepted and partially accepted submissions from

2025 public consultation and the MDCG Nomenclature

working group

Updates coming from accepted and partially accepted requests are reported in different colours, as following:

• • green for added levels
• • red for deleted levels
• • light blue for term update

MEDICAL TRANSFER NEEDLES

CODE TERM LEVEL TERMINAL LEVEL

A0190 NEEDLES FOR OTHER PROCEDURES 3 N

A019001 BLUNT NEEDLES 4 Y

A019002 ACUPUNCTURE NEEDLES 4 Y

... ... ... ...

A019014 LUMBAR PUNCTURE NEEDLES AND KITS 4 Y

A019015 PERI- AND NEO-NATAL EPICRANIAL NEEDLES 4 Y

A019016 BRACHYTHERAPY NEEDLES 4 Y

A019017 FILL, TRANSFER AND RECONSTITUTION NEEDLES FOR FLUIDS AND MEDICATION 5 N

A01901701 FILL, TRANSFER AND RECONSTITUTION NEEDLES FOR FLUIDS AND MEDICATION WITHOUT FILTER 6 Y

A01901702 FILL, TRANSFER AND RECONSTITUTION FILTER NEEDLES FOR FLUIDS AND MEDICATION 6 Y

A019099 NEEDLES FOR OTHER PROCEDURES – OTHER 4 Y

OUTCOME: PARTIALLYACCEPTED

REQUEST: INSERT

• A019017 MEDICATION TRANSFER NEEDLES

• A019018 MEDICATION FILTER NEEDLES

MEDICAL TUBES CONNECTORS

REQUEST: INSERT A070104 MEDICAL TUBES CONNECTORS

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

A07 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS 2 N

A0701 ADAPTERS AND CONNECTORS 3 N

A070101 ASPIRATION LINES SUCTION TUBING ADAPTERS AND CONNECTORS 4 Y

A070102 IRRIGATION LINES TUBING ADAPTERS AND CONNECTORS 4 Y

A070103 INFUSION LINES TUBING ADAPTERS AND CONNECTORS 4 Y

A070199 ADAPTERS AND CONNECTORS-OTHER 4 Y

ANGIOGRAPHY AND HAEMODYNAMIC DEVICES

REQUEST: INSERT A SECTION FOR NEUROVASCULAR ANGIOGRAPHY DEVICES

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

C0104 ANGIOGRAPHY AND HAEMODYNAMIC DEVICES 3 N

C010401 CARDIAC ANGIOGRAPHY DEVICES 4 N

C010402 PERIPHERAL ANGIOGRAPHY DEVICES 4 N

... .... ... ...

C010404 NEUROVASCULAR ANGIOGRAPHY DEVICES 4 N

C01040401 NEUROVASCULAR ANGIOGRAPHY DIAGNOSTIC DEVICES 5 N

C0104040101 NEUROVASCULAR OCCLUSION CATHETERS 6 Y

C0104040180 NEUROVASCULAR ANGIOGRAPHY DIAGNOSTIC DEVICES-ACCESSORIES 6 Y

C0104040199 NEUROVASCULAR ANGIOGRAPHY DIAGNOSTIC DEVICES – OTHER 6 Y

C01040402 NEUROVASCULAR ANGIOGRAPHY THERAPEUTIC DEVICES 5 N

C0104040201 NEUROVASCULAR EMBOLISATION CATHETERS AND MICROCATHETERS 6 Y

C0104040202 NEUROVASCULAR EMBOLISATION DEVICES 6 N

C010404020201 NEUROVASCULAR EMBOLISATION COILS 7 Y

C010404020202 NEUROVASCULAR MECHANICAL ASSISTANCE DEVICES FOR EMBOLISATION PROCEDURE 7 Y

C010404020280 NEUROVASCULAR EMBOLISATION DEVICES-ACCESSORIES 7 Y

C010404020299 NEUROVASCULAR EMBOLISATION DEVICES-OTHER 7 Y

C0104040203 NEUROVASCULAR ANGIOGRAPHY GUIDE CATHETERS 6 Y

C0104040204 NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS 6 N

C010404020401 MANUAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS 7 Y

C010404020402 MECHANICAL NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS 7 Y

C010404020480 NEUROVASCULAR THROMBECTOMY AND THROMBOASPIRATION SYSTEMS-ACCESSORIES 7 Y

C0104040280 NEUROVASCULAR ANGIOGRAPHY THERAPEUTIC DEVICES-ACCESSORIES 6 Y

C0104040299 NEUROVASCULAR ANGIOGRAPHY THERAPEUTIC DEVICES-OTHER 6 Y

ANGIOGRAPHY AND HAEMODYNAMIC DEVICES - GUIDEWIRES

OUTCOME: PARTIALLYACCEPTED

REQUEST: UPDATE C0403 from CORONARY AND PERIPHERAL VASCULAR GUIDEWIRES to NEUROVASCULAR GUIDEWIRES

CODE TERM LEVEL TERMINAL LEVEL

C04 CARDIOVASCULAR GUIDEWIRES 2 N

C0401 CORONARY ARTERY GUIDEWIRES 3 N

... ... ... ...

C0402 PERIPHERAL VASCULAR GUIDEWIRES 3 N

... ... ... ...

C0403 CORONARY AND PERIPHERAL VASCULAR GUIDEWIRES 3 N

... ... ... ...

C0404 NEUROVASCULAR GUIDEWIRES 3 N

C040401 NEUROVASCULAR DIAGNOSTIC GUIDEWIRES 4 N

C04040101 NEUROVASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC 5 Y

C04040102 NEUROVASCULAR DIAGNOSTICGUIDEWIRES, NON-HYDROPHILIC 5 Y

C04040199 NEUROVASCULAR DIAGNOSTICGUIDEWIRES-OTHER 5 Y

C040402 NEUROVASCULAR THERAPEUTIC GUIDEWIRES 4 N

C04040201 NEUROVASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC 5 Y

C04040202 NEUROVASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC 5 Y

C04040299 NEUROVASCULAR THERAPEUTIC GUIDEWIRES-OTHER 5 Y

SUTURE PASSER (LAPAROSCOPIC AND THORACOSCOPIC FASCIAL CLOSURE SYSTEM)

CODE TERM LEVEL TERMINAL LEVEL

H SUTURE DEVICES 1 N

... ... ... ...

H90 SUTURE DEVICES – VARIOUS 2 N

H9001 TISSUE ADHESIVES 3 N

H9002 TAPES, MEDICAL/SURGICAL 3 N

H9003 SUTURE REINFORCEMENT OR SUPPORT DEVICES 3 N

H9005 SUTURE ZIPPERS 3 Y

H9006 CRANIAL HOLE COVERS 3 Y

H9007 ANCHORS FOR SOFT TISSUE SUTURE (excluding P09120102 ANCHORS FOR TENDON-LIGAMENT SYNTHESIS) 3 Y

H9008 SINGLE-USE SUTURE INSTRUMENTS 3 N

... ... ... ...

H900802 SINGLE-USE NEEDLE HOLDERS 4 Y

H900803 SINGLE-USE SUTURE PASSER AND PORT/FASCIAL CLOSURE SYSTEMS 4 Y

H900899 SINGLE-USE INSTRUMENTS FOR SUTURES-OTHER 4 Y

REQUEST: INSERT H90XX SUTURE PASSER

OUTCOME: PARTIALLYACCEPTED

REQUEST:

• UPDATE

✓ J0301 from COCHLEAR IMPLANTABLE DEVICES to COCHLEAR IMPLANTS ✓ J0302 from MIDDLE EAR ACTIVE-IMPLANTABLE DEVICES to MIDDLE EAR IMPLANTS ✓ J0303 from PROFOUND DEAFNESS BRAINSTEM ACTIVE-IMPLANTABLE DEVICES to AUDITORY BRAINSTEM IMPLANTS

• INSERT J0304 BONE CONDUCTION HEARING IMPLANTS

HEARING IMPLANTS

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

J03 AUDITORY ACTIVE-IMPLANTABLE DEVICES 2 N

J0301 COCHLEAR IMPLANTABLE DEVICES IMPLANTS 3 Y

J0302 MIDDLE EAR ACTIVE-IMPLANTABLE DEVICES IMPLANTS 3 Y

J0303 PROFOUND DEAFNESS AUDITORY BRAINSTEM IMPLANTS ACTIVE-IMPLANTABLE DEVICES 3 Y

J0304 BONE CONDUCTION IMPLANTS 3 Y

J0380 AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES 3 Y

J0399 AUDITORY ACTIVE-IMPLANTABLE DEVICES - OTHER 3 Y

ROBOTIC SURGERY TROCARS – SINGLE USE

CODE TERM LEVEL TERMINAL LEVEL

K0101 TROCAR AND KITS, SINGLE-USE 3 N

K010101 TROCAR, SINGLE-USE 4 N

K01010101 TROCAR STANDARD, SINGLE-USE 5 Y

K01010102 HASSON TROCAR, SINGLE-USE 5 Y

K01010103 OPTICAL TROCAR, SINGLE-USE 5 Y

K01010104 THORACIC TROCAR, SINGLE-USE 5 Y

K01010105 SPECIAL TROCAR, SINGLE-USE 5 Y

K01010106 ROBOTIC SURGERY TROCAR, SINGLE-USE 5 Y

K01010180 TROCAR, SINGLE-USE - ACCESSORIES 5 Y

K01010199 TROCAR, SINGLE-USE - OTHER 5 Y

REQUEST: INSERT K01020206 ROBOTIC SURGERY TROCARS, SINGLE-USE

OUTCOME: PARTIALLYACCEPTED

ROBOTIC SURGERY TROCARS - REUSABLE

REQUEST: INSERT L1310 ROBOTIC SURGERY TROCARS, REUSABLE

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

L0312 SURGICAL TROCAR, REUSABLE 2 N

L031201 THORACIC TROCAR, REUSABLE 3 Y

L031202 ABDOMINAL TROCAR, REUSABLE 3 Y

L031203 OTOLARYNGOLOGICAL SURGERY TROCAR, REUSABLE 3 Y

L031204 ARTHROSCOPIC SURGERY TROCAR, REUSABLE 3 Y

L031205 ORTHOPAEDIC SURGERY TROCAR, REUSABLE 3 Y

L031206 ROBOTIC SURGERY TROCAR, REUSABLE 3 Y

L031280 SURGICAL TROCAR, REUSABLE-ACCESSORIES 3 Y

L031299 SURGICAL TROCAR, REUSABLE-OTHER 3 Y

ROBOTIC SURGERY INSTRUMENTS

REQUEST: INSERT

• L1308 ROBOTIC SURGERY GRASPERS, REUSABLE

• L1309 ROBOTIC SURGERY NEEDLE DRIVERS, REUSABLE

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

L13 ROBOTIC SURGERY INSTRUMENTS, REUSABLE 2 N

L1301 ROBOTIC SURGERY SCALPELS, REUSABLE 3 Y

L1302 ROBOTIC SURGERY CLIPS, REUSABLE 3 Y

L1303 ROBOTIC SURGERY SCISSORS, REUSABLE 3 Y

L1304 ROBOTIC SURGERY FORCEPS AND GRASPERS, REUSABLE 3 Y

L1305 ROBOTIC SURGERY SPREADERS AND RETRACTORS, REUSABLE 3 Y

L1306 ULTRASONIC GENERATOR ROBOTIC SURGERY INSTRUMENTS, REUSABLE 3 Y

L1307 ROBOTIC SURGERY INSTRUMENT KITS, REUSABLE 3 Y

L1308 ROBOTIC SURGERY NEEDLE HOLDERS, REUSABLE 3 Y

L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE-OTHER 3 Y

DENTAL RESTORATIVE COMPOSITES

REQUEST: UPDATE Q01010103 from DENTAL CONSERVATION COMPOSITES to DENTAL RESTORATIVE COMPOSITES

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

Q010101 DENTAL RESTORATION DEVICES 4 N

Q01010101 DENTAL CONSERVATIONAMALGAMS FOR RESTORATIVE DENTISTRY 5 Y

Q01010102 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS 5 N

... ... ... ...

Q01010103 DENTAL CONSERVATIONRESTORATIVECOMPOSITES 5 Y

Q01010104 DENTAL BONDING AGENTS 5 Y

Q01010105 DENTAL RESTORATION COMPOMERS 5 Y

Q01010106 DENTAL RESTORATION GLASS IONOMERS 5 Y

Q01010199 DENTAL RESTORATION DEVICES-OTHER 5 Y

ROOT CANAL IRRIGATION SOLUTIONS

REQUEST: INSERT Q010106 ROOT CANAL IRRIGATION SOLUTIONS

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

Q0101 DENTAL RESTORATION DEVICES 3 N

Q010101 DENTAL CONSERVATION AMALGAMS 4 N

... ... ... ...

Q010102 ROOT CANAL FILLING DEVICES 4 N

... ...

Q010103 DENTAL IRRIGATION AND MEDICATION DEVICES 4 N

Q01010301 DENTAL MEDICATION COMPOUNDS WITH DISINFECTANTS, ANTIBIOTICS AND ANTI-INFLAMMATORIES 5 Y

Q01010302 SOLUTIONS FOR CANAL IRRIGATION 5 Y

Q010104 DENTAL PROCEDURE DEVICES-VARIOUS 4 N

... ... ... ...

Q010105 RECONSTRUCTION ENDODONTIC PINS 4 Y

ENDOBRONCHIAL BLOCKERS

REQUEST: INSERT R010403 ENDOBRONCHIAL TUBES-SINGLE LUMEN

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

R0104 ONE LUNG VENTILATION DEVICES (OLV) ENDOBRONCHIAL TUBES 3 N

R010401 ENDOBRONCHIAL DOUBLE LUMEN TUBES, RIGHT 4 N

R01040101 ENDOBRONCHIAL TUBES, RIGHT, SINGLE-LUMEN 5 Y

R01040102 ENDOBRONCHIAL OROPHARYNGEAL TUBES, RIGHT, DOUBLE-LUMEN 5 Y

R01040103 ENDOBRONCHIAL TUBES, RIGHT, DOUBLE-LUMEN, TRACHEOSTOMY 5 Y

R01040199 ENDOBRONCHIAL TUBES, RIGHT-OTHER 5 Y

R010402 ENDOBRONCHIAL DOUBLE LUMEN TUBES, LEFT 4 N

R01040201 ENDOBRONCHIAL TUBES, LEFT, SINGLE-LUMEN 5 Y

R01040202 ENDOBRONCHIAL OROPHARYNGEALTUBES, LEFT,DOUBLE-LUMEN 5 Y

R01040203 ENDOBRONCHIAL TUBES, LEFT, DOUBLE-LUMEN, TRACHEOSTOMY 5 Y

R01040299 ENDOBRONCHIAL TUBES, LEFT-OTHER 5 Y

R010403 ENDOBRONCHIAL BLOCKERS 4 Y

R010404 SINGLE LUMEN TUBES EQUIPPED WITH AN ENDOBRONCHIAL BLOCKER 4 Y

R010480 ONE LUNG VENTILATION DEVICES (OLV) ENDOBRONCHIAL TUBES-ACCESSORIES 4 Y

R010499 ONE LUNG VENTILATION DEVICES (OLV) ENDOBRONCHIAL TUBES-OTHER 4 Y

GEL FOR ERECTILE DYSFUNCTION

REQUEST: INSERT

• U14 SINGLE-USE DEVICES FOR SEXUAL DYSFUNCTIONS

• U1401 SINGLE-USE DEVICES FOR MALE SEXUAL DYSFUNCTIONS

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

U01 URETHRAL, PROSTATIC AND BLADDER CATHETERS 2 N

U02 URETERAL CATHETERS AND STENTS 2 N

U03 DEVICES FOR URETHRAL, URETERAL AND NEPHROSTOMY CATHETERS 2 N

U04 DEVICES FOR PERCUTANEOUS URINARY DRAINAGE AND NEPHROSTOMY CATHETERS 2 N

U05 URODYNAMICS DEVICES 2 N

U06 UROLOGICAL GUIDEWIRES 2 N

U07 DEVICES FOR THE TREATMENT OF INCONTINENCE 2 N

U08 GYNAECOLOGICAL DEVICES 2 N

... ... ... ...

U13 SOLUTIONS AND KITS FOR BLADDER WASHING AND INSTILLATION 2 N

U14 NON-IMPLANTABLE DEVICES FOR SEXUAL DYSFUNCTION 2 Y

U99 DEVICES FOR UROGENITAL SYSTEM-OTHERS 2 Y

CONTACT DIGITAL THERMOMETERS

REQUEST: INSERT V03010102XX (CONTACT) DIGITAL THERMOMETERS-Accessories/Probe

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

V VARIOUS MEDICAL DEVICES 1 N

... ... ... ...

V03 MEASUREMENT DEVICES 2 N

V0301 BODY TEMPERATURE MEASUREMENT DEVICES 3 N

V030101 THERMOMETERS 4 N

V03010102 DIGITAL THERMOMETERS 5 N

V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) 6 Y

V0301010202 NON CONTACT DIGITAL THERMOMETERS 6 Y

V0301010299 DIGITAL THERMOMETERS-OTHERS 6 Y

LIQUID CRYSTAL BODY TEMPERATURE INDICATORS

REQUEST: INSERT new code for liquid crystal temperature indicators in V03 MEASUREMENT DEVICES

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

V VARIOUS MEDICAL DEVICES 1 N

... ... ... ...

V03 MEASUREMENT DEVICES 2 N

V0301 BODY TEMPERATURE 3 N

V030101 THERMOMETERS 4 N

V03010102 DIGITAL THERMOMETERS 5 N

V03010104 LIQUID EXPANSION THERMOMETERS 5 Y

V03010105 LIQUID CRYSTAL BODY TEMPERATURE INDICATORS 5 Y

V03010199 THERMOMETERS-OTHERS 5 Y

SLIDE SHEET (SINGLE-USE) AND TRANSPORT SHEET (SINGLE-USE)

REQUEST: INSERT in V08 new codes for MEDICAL DISPOSABLE BEDDING PATIENT POSITIONING SHEET (DISPOSABLE SLIDE SHEET) – SINGLE USE and MEDICAL DISPOSABLE BEDDING TRANSPORT SHEET – SINGLE USE-NON STERILE

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

V08 HEALTHCARE ACTIVITIES SUPPORTIVE EQUIPMENT AND AIDS 2 N

... ...

V0805 PATIENT TRANSFER EQUIPMENT 3 N

... ...

V080501 PATIENT TRANSFER STRETCHERS 4 N

V080502 PATIENT TRANSFER CHAIRS 4 N

V080503 PATIENT TRANSFER LIFTS 4 N

V080504 PATIENT TRANSFER BOARDS AND TABLES 4 N

V080505 PATIENT TRANSFER SHEETS AND MATTRESSES 4 Y

V0806 MEDICAL BEDS 3 N

... ... ... ...

PRESEPSIN

REQUEST: INSERT W0105070204 - SEPSIS - Soluble CD14 subtype (PRESEPSIN)

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

W01020190 OTHER SPECIFIC PROTEINS 5 N

W0102019001 A1-ACID GLYCOPROTEIN (OROSOMUCOID) 6 Y

W0102019002 A1-ANTITRYPSIN (PROTEASE INHIBITOR) 6 Y

... ... ... ...

W0102019012 AMYLOID BETA-DERIVED DIFFUSIBLE LIGAND (BETA-AMYLOID OLIGOMER) 6 Y

W0102019013 BETA-AMYLOID (1-40) 6 Y

W0102019014 BETA-AMYLOID (1-42) 6 Y

W0102019015 TOTAL TAU 6 Y

W0102019016 HUMAN TAU (HTAU) 6 Y

W0102019017 PHOSPHORYLATED TAU (PTAU) 6 Y

W0102019018 PRESEPSIN (solubleCD14 or sCD14) 6 Y

W0102019019* NEUROFILAMENT LIGHT CHAIN (NFL) 6 Y

W0102019099 SPECIFIC PROTEINS-OTHER 6 Y

*Code not included in EMDN v.2025; it was added in EMDN v.2026 based on input other than submissions from the 2025 public consultation and the Nomenclature WG

EQUIPMENT FOR PANORAMIC DENTAL IMAGING, CEPHALOMETRY, AND CARPUS (INCLUDING CBCT)

CODE TERM LEVEL TERMINAL LEVEL

Z11 BIOIMAGING AND RADIOTHERAPY INSTRUMENTS 2 N

... ... ... ...

Z1103 DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS 3 N

... ... ... ...

Z110303 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGYORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY 4 N

Z11030301 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY ORTHOPANTOMOGRAPHY 5 N

Z1103030101 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY , CONVENTIONAL ORTHOPANTOMOGRAPHY 6 Y

Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY , DIGITAL ORTHOPANTOMOGRAPHY 6 Y

Z11030302 EQUIPMENT FOR PANORAMIC DENTAL RADIOLOGY 5 Y

Z11030380 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGYORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY- HARDWARE

ACCESSORIES 5 Y

Z11030382 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGYORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY- SOFTWARE

ACCESSORIES 5 Y

Z11030385 INSTRUMENTSFOR EXTRAORAL DENTAL RADIOLOGYORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY-CONSUMABLES 5 Y

Z11030392 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGYORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY- MEDICAL

DEVICE SOFTWARE 5 Y

... ... ... ...

Z110304 INSTRUMENTS FOR ENDORAL RADIOLOGY 4 N

REQUEST:

• • UPDATE Z110303 from INSTRUMENTS FOR ORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY to INSTRUMENTS FOR ORTHOPANTOMOGRAPHYAND PANORAMIC DENTALRADIOLOGY and sub-levels accordingly
• • DELETE Z11030301 EQUIPMENT FOR ORTHOPANTOMOGRAPHYor Z11030302 EQUIPMENT FOR PANORAMIC DENTAL RADIOLOGY

OUTCOME: PARTIALLYACCEPTED

VITAL SIGNS TELEMETRY INSTRUMENTS

REQUEST: MOVING Z120306 section under Z120302 VITAL SIGNS MONITORING INSTRUMENTS, inserting a new section Z12030206

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL

LEVEL

Z1203

INSTRUMENTS TO SUPPORT AND MONITOR VITAL

SIGNS 3 N

... ... ... ...

Z120302 VITAL SIGNS MONITORING INSTRUMENTS 4 N

Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS 5 Y

... ... .. ..

Z12030206 VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...) 5 N

Z12030280 VITAL SIGNS MONITORING INSTRUMENTS -

HARDWARE ACCESSORIES 5 Y

Z12030282 VITAL SIGNS MONITORING INSTRUMENTS -

SOFTWARE ACCESSORIES 5 Y

Z12030285

VITAL SIGNS MONITORING INSTRUMENTS -

CONSUMABLES 5 Y

Z12030292

VITAL SIGNS MONITORING INSTRUMENTS -

MEDICAL DEVICE SOFTWARE 5 Y

Z12030299 VITAL SIGNS MONITORING INSTRUMENTS-OTHER 5 Y

... ... ... ...

Z120306 VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...) 4 N

... ... ... ... 33

CODE TERM LEVEL TERMINAL

LEVEL

Z12030206 VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...) 5 N

Z1203020601 COMPLETE VITAL SIGNS TELEMETRY SYSTEMS 6 Y

Z1203020602 VITAL SIGNS TELEMETRY RECEIVERS 6 Y

Z1203020603 VITAL SIGNS TELEMETRY TRANSMITTER 6 Y

Z1203020680 VITAL SIGNS TELEMETRY INSTRUMENTS -

HARDWARE ACCESSORIES 6 Y

Z1203020682 VITAL SIGNS TELEMETRY INSTRUMENTS - SOFTWARE

ACCESSORIES 6 Y

Z1203020685 VITAL SIGNS TELEMETRY INSTRUMENTS -

CONSUMABLES 6 Y

Z1203020692 VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL

DEVICE SOFTWARE 6 Y

CODE TERM LEVEL TERMINAL

LEVEL

Z120306 VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...) 4 N

Z12030601 COMPLETE VITAL SIGNS TELEMETRY SYSTEMS 5 Y

Z12030602 VITAL SIGNS TELEMETRY RECEIVERS 5 Y

Z12030603 VITAL SIGNS TELEMETRY TRANSMITTER 5 Y

Z12030680 VITAL SIGNS TELEMETRY INSTRUMENTS - HARDWARE

ACCESSORIES 5 Y

Z12030682 VITAL SIGNS TELEMETRY INSTRUMENTS - SOFTWARE

ACCESSORIES 5 Y

Z12030685 VITAL SIGNS TELEMETRY INSTRUMENTS-CONSUMABLES 5 Y

Z12030692 VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL

DEVICE SOFTWARE 5 Y

THAWERS FOR BLOOD AND BLOOD COMPONENTS

CODE TERM LEVEL TERMINAL LEVEL

Z MEDICAL EQUIPMENT AND RELATED ACCESSORIES, SOFTWARE AND CONSUMABLES 1 N

Z11 BIOIMAGING AND RADIOTHERAPY INSTRUMENTS 2 N

Z12 INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS 2 N

... ... ... ...

Z1217 BLOOD TRANSFUSION INSTRUMENTS 3 N

Z121701 BLOOD BANK REFRIGERATORS 4 Y

Z121702 BLOOD AND BLOOD COMPONENTS PLASMA FREEZERS 4 Y

Z121703 BLOOD AND BLOOD COMPONENTS PLASMA THAWERS 4 Y

Z121780 BLOOD TRANSFUSION INSTRUMENTS-HARDWARE ACCESSORIES 4 Y

Z121799 BLOOD TRANSFUSION INSTRUMENTS-HARDWARE-OTHER 4 Y

34

REQUEST:

• • UPDATE Z121703 from PLASMA THAWERS to BLOOD PRODUCTS THAWERS

• INSERT

✓ Z12170301 PLASMA THAWERS

✓ Z12170302 CRYOPRESERVED BLOOD PRODUCTS THAWERS

✓ Z12170399 BLOOD PRODUCTS THAWERS – OTHER

OUTCOME: PARTIALLYACCEPTED