Summary of EMDN 2024 Submissions and outcome of annual revision

MDCG 2025-2

EMDN UPDATE SUBMISSIONS FROM 2024

PUBLIC CONSULTATION AND THE MDCG

NOMENCLATURE WORKING GROUP

OUTCOME OF THE ANALYSIS OF SUBMISSIONS

1. ACCEPTED

2. PARTIALLY ACCEPTED

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

3. NOT ACCEPTED

Eg. ✓ 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 compliance with the nomenclature structure.

1.Not accepted submissions from 2024 public

consultation and the MDCG Nomenclature working

group

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT H010101020101 -

Request not integrated/integrated with no sufficient information/technical details. INSERT V Visual timer that can be used by therapists, schools, people with special needs, and home use. Request not integrated/integrated with no sufficient information/technical details. INSERT Q0190 New code Q019009-Intraoral Camera Intraoral cameras are necessary for accurate diagnosis and treatment. Request not integrated/integrated with no sufficient information/technical details.

UPDATE T0399 -

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

OUTCOME: NOT ACCEPTED-INSUFFICIENT INFORMATION

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT C

C010404 NEUROVASCULAR ANGIOGRAPHY DEVICES

C01040402 NEUROVASCULAR ANGIOGRAPHY THERAPEUTIC DEVICES

C0104040204 NEUROVASCULAR ANGIOGRAPHY GUIDE CATHETERS is intended as a conduit device for the intravascular introduction of interventional/ diagnostic devices to the neuro vasculature.

The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (referto the level C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS). According to the structure of nomenclature peripheral devices include devices for neurovascular scope.

INSERT C

C010404 NEUROVASCULAR ANGIOGRAPHY DEVICES, C01040402 NEUROVASCULAR ANGIOGRAPHY THERAPEUTIC DEVICES

C0104040202 NEUROVASCULAR EMBOLISATION CATHETERS AND MICROCATHETERS is intended as a conduit for endovascular use during diagnostic and/or interventional procedures in the peripheral and neuro vasculature.

The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (referto the existing level C0104020202

PERIPHERAL EMBOLISATION CATHETERS AND

MICROCATHETERS). According to the structure of nomenclature peripheral devices include devices for neurovascular scope.

INSERT C

C010404 NEUROVASCULAR ANGIOGRAPHY DEVICES

C01040402 NEUROVASCULAR ANGIOGRAPHY THERAPEUTIC DEVICES

C0104040203 EMBOLISATION DEVICES

C010404020301 EMBOLISATION COILS is intended for endovascular embolization in the neurovasculature

The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (referto C0104020203 EMBOLISATION DEVICES and the bottom level C010402020301 EMBOLISATION COILS). According to the structure of nomenclature peripheral devices include devices for neurovascular scope.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT C

C0403 NEURO VASCULAR GUIDEWIRES

C040301 NEURO VASCULAR DIAGNOSTIC GUIDEWIRES

C04030101 NEURO VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC intended to navigate vessels to access a lesion or vessel segment for selective placement of microcatheters and other neurovascular devices.

The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to C040201 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES and relatedbottom levels). According to the structure of nomenclature peripheral guidewires include guidewires for neurovascular scope.

INSERT C

C0403 NEURO VASCULAR GUIDEWIRES

C040302 NEURO VASCULAR THERAPEUTIC GUIDEWIRES

C04030201 NEURO VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC intended to navigate vessels to access a lesion or vessel segment for selective placement of microcatheters and other neurovascular devices.

The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to C040202 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES and relatedbottom levels). According to the structure of nomenclature peripheral guidewires include guidewires for neurovascular scope.

INSERT C

C07-NEUROVASCULAR SYSTEMS DEVICES

C0701-NEUROVASCULAR THROMBECTOMY SYSTEM DEVICES

C0702-NEUROVASCULAR MICROCATHETERS

C0703-NEUROVASCULAR COILS

C0704-NEUROVASCULAR ASPIRATION CATHETERS

C0705-NEUROVASCULAR GUIDEWIRE SYSTEM DEVICES

Neurovascular devices are used in neurovasculature, therefore, within cardiocirculatory system. Currently there are no existing codes for neurovascular devices. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to C010402 PERIPHERAL ANGIOGRAPHY DEVICES and C0402 PERIPHERAL VASCULAR GUIDEWIRES and relatedbottom levels). According to the structure of nomenclature peripheral devices include devices with neurovascular scope.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT

H03010106 - REUSABLE MULTIPLE CLIP

APPLIERS FOR OPEN SURGERY (consider using: H03010103) intended to deliver and close metallic ligating clips The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (referto the level L020801-MULTIPLE CLIPS APPLICATORS FOR OPEN SURGERY , REUSABLE). INSERT K01010106-TROCAR ABDOMINAL, SINGLE-USE intended to establish a path 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 (referto the level K01010101-TROCAR STANDARD, SINGLE-USE).

UPDATE

K020180 - Single- and bipolar device - accessories) Change is necessary as there is no existing code for reusable accessories. For example power cables. The feature of single-use refersto SINGLE- AND BIPOLAR DEVICES. Accessories of single-and bipolar devices can be both single-use and reusable.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT P09080408 – HIP

PROSTHESIS ADAPTERS a new code and term for the EMDN date base (P09080408 – HIP PROSTHESIS ADAPTERS).

Any kind of adapters in femoral hip arthroplasty could be currently just listed under P9088004 – HIP PROSTHESIS ADAPTERS. However this code is listed under P90880 - HIP PROTHESIS - ACCESSORIES. The affected device however is a class III implantable, surgically invasive medical device intended for longterm- use according to rule 8, indent 8 of Annex VIII of the MDR. Therefore it cannot be classified as accessory and would need an own EMDN code please. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to P9088004 – HIP PROSTHESIS ADAPTERS). INSERT P9006 - Cranial resinous compounds Intended purpose: intended for the repair of cranial defects. Description: a two-component (powder and liquid) radiopaque, polymethylmethacrylate (PMMA) acrylic resin. The resin components are designed for mixing together at the point of use to form a cement which can be manually moldedto fill a cranial defect providing brain protection. Sterile and single use. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to P9004 STRUCTURES

FILLING, REPLACEMENT AND

RECONSTRUCTION DEVICES and related bottom levels).

INSERT P9005 - CUSTOM MADE

CRANIAL IMPLANTS

Intended purpose: designed individually for each patient to correct trauma and/or defects in cranial bones. Description: made of cured PMMA resin or PMMA with the addition of gentamicin or PMMA with the addition gentamicin and vancomycin The shape of the device is designed each time, patient for patient, on the basis of the request of the surgeonthat supplies to “Manufacturer Name" a digital image (CT scan) of the cranial defect. Each custom-made "Device Name" is provided in duplicate: one copy is for implant and the other is a backup copy in case the first one is damaged or looses sterility. These devices are supplied sterile and for single use. Based on the documentation provided by the user (statement according to Annex XIII and QMS certificate) the device is a custom made device (CMD). CMDs are not required to be registered in the UDI-DI module in EUDAMED. Therefore, an EMDN code is not necessary.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT Q010104 SINGLE-USE SURGICAL INSTRUMENTS There is the code L for reusable instruments but not one for single-use instruments. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN (refer to Q0105

INSTRUMENTS FOR DENTISTRY , SINGLE-USE and related bottom levels).

UPDATE Q010507 - ENDODONTIC INSTRUMENTS (CANAL

ENLARGERS, FILES, RASPS, ETC.)

Not all endodontic instruments on the market are single-use. It would be better if the code Q010507 did not indicate the number of uses. Refer to L15 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE and related bottom levels.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT

U0904 - UROGENITAL

ENDOSCOPIC SHEATH intended to establish a path 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 L060407 ENDOSCOPIC UROLOGY SHEATHS REUSABLE and

Z120207 GENITOURINARY ENDOSCOPY INSTRUMENTS and relatedbottom levels).

U090401 - UROGENITAL

ENDOSCOPIC INNER

SHEATH

Intended use: the products are used to supply irrigation fluid and to hold working elements and working inserts.

U090402- UROGENITAL

ENDOSCOPIC OUTER

SHEATH

Intended use: the products are used to access the surgical area and to remove irrigation fluid and resected tissue.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

TYPE OF

REQUEST CODE SUPPORT INFO RATIONAL

INSERT Z120298 - ENDOSCOPE -

OTHER

There are endoscopes that can be used for different applications. The choice is made by the surgeon. These products cannot yet be assigned an EMDN code, as several EMDN codes are applicable for one device. For example, there are endoscopes that can be used for both laparoscopy and thorascopydue to their design. For this reason, a generic EMDN code for endoscopes should be added. The inclusion of new levels is planned to include types of devices not present in the current version of the EMDN. If relevant, multiple codes can be assigned to the same UDI- DI.

MOVING

Z120306-VITAL SIGNS

TELEMETRY INSTRUMENTS

(ECG, NIPB, EtCO2, SpO2,

RESPIRATION,...)

Move "Z120306-VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...)" and its underlying levels below "Z120302-Vital Signs Monitoring Instruments"“ "Z120306 - VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...)" creates a group for telemetry devices. However, through the current hierarchy it is not connected with the code group "Z120302 - Vital Signs Monitoring Instruments" which includes products related to vital signs monitoring (such as bedside or portable patient monitors which share a very similar intended purpose to vital signs telemetry devices). The request is not aimed to correct an improper place of an existing level and related bottom levels. The current version of EMDN provides the codes necessary to register different kinds of devices intended to monitor vital signs.

OUTCOME: NOT ACCEPTED-OUT OF SCOPE OF EMDN UPDATE

2.Accepted and partially accepted submissions from

2024 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 editing;

ENDOSCOPIC APPLICATOR

CODE TERM LEVEL TERMINAL LEVEL

A DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION 1 N

A01 NEEDLES 2 N

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

A12 SAMPLE COLLECTION SPATULAS 2 Y

A13 APPLICATORS FOR DRUGS AND MEDICAL DEVICES NOT PRESENT IN OTHER CLASSES 2 Y

A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION-OTHER 2 Y

OUTCOME: PARTIALLYACCEPTED

REQUEST: INSERT

• A0305 ADMINISTRATION DEVICES G0601-REUSABLE STOMAL DILATORS FOR HOME CARE THERAPY

• A030501 ENDOSCOPIC APPLICATOR

REUSABLE GASTROINTESTINAL DILATORS FOR HOME CARE THERAPY

REQUEST: INSERT

• G06-REUSABLE GASTROINTESTINAL DILATORS FOR HOME CARE THERAPY

• G0601-REUSABLE STOMAL DILATORS FOR HOME CARE THERAPY

• G0602-REUSABLE ANAL DILATORS FOR HOME CARE THERAPY

CODE TERM LEVEL TERMINAL LEVEL

A DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION 1 N

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

A10 ABDOMINAL OSTOMY DEVICES 2 N

A1001 ONE PIECE ABDOMINAL OSTOMY DEVICES 3 N

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

A1080 ABDOMINAL OSTOMY DEVICES-ACCESSORIES 3 N

A108001 RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN 4 Y

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

A108009 ABDOMINAL OSTOMY DILATORS 4 Y

A108099 ACCESSORY DEVICES FOR ABDOMINAL OSTOMY-OTHER 4 Y

CODE TERM LEVEL TERMINAL LEVEL

G GASTROINTESTINAL DEVICES 1 N

G01 ORO-OESOPHAGEAL TUBES 2 N

... ... 2 Y

G06 ANAL DILATORS 2 Y

G99 GASTROINTESTINAL DEVICES-OTHER 2 Y

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

C020101 ARRHYTHMOLOGY BIPOLAR LEADS 4 Y

C020102 ARRHYTHMOLOGY TRIPOLAR LEADS 4 Y

C020103 ARRHYTHMOLOGY TETRAPOLAR LEADS 4 Y

C020104 ARRHYTHMOLOGY MULTIPOLAR LEADS 4 N

C02010401 ARRHYTHMOLOGY MULTIPOLAR LEADS, CONVENTIONAL 5 Y

C02010402 ARRHYTHMOLOGY MULTIPOLAR LEADS, BASKET TYPE 5 Y

C02010403 ARRHYTHMOLOGY MULTIPOLAR LEADS, ADJUSTABLE 5 Y

C02010499 ARRHYTHMOLOGY MULTIPOLAR LEADS – OTHER 5 Y

C020105 NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL LEADS 4 Y

ARRHYTHMOLOGY LEADS

15

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

C020101 ARRHYTHMOLOGY BIPOLAR DIAGNOSTICCATHETERS 4 Y

C020102 ARRHYTHMOLOGY TRIPOLAR DIAGNOSTIC CATHETERS 4 Y

C020103 ARRHYTHMOLOGY TETRAPOLAR DIAGNOSTIC CATHETERS 4 Y

C020104 ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS 4 N

C02010401 ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL 5 Y

C02010402 ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, BASKET TYPE 5 Y

C02010403 ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE 5 Y

C02010499 ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS – OTHER 5 Y

C020105 NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS 4 Y

REQUEST: EDIT THE FOLLOWING TERMS BY CHANGHING “ ELECTROCATHETERS " TO “ LEAD "

ARRHYTHMOGENIC FOCI ABLATION DEVICES

REQUEST:

• EDIT THE TERMS FOR ARRHYTHMOGENIC FOCI ABLATION DEVICES BY CHANGING THE “ELECTROCHATETERS TO "LEADS

• INSERT C020304 ARRHYTHMOGENIC FOCI ABLATION DEVICES VIA PULSED FIELD ENERGY

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

C CARDIOCIRCULATORY SYSTEM DEVICES 1 N

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

C02 ARRHYTHMOLOGY DEVICES 2 N

C0203 CARDIAC TISSUE ABLATION DEVICES 3 N

C020301 ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS 4 Y

C020302 ARRHYTHMOGENIC FOCI CRYOENERGY ABLATION CATHETERS 4 Y

C020303 ARRHYTHMOGENIC FOCI ABLATION LEADS VIA OTHER ENERGY SOURCES 4 Y

C020304 ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS 4 Y

C020305 ARRHYTHMOGENIC FOCI LASER ABLATION CATHETERS 4 Y

C020380 ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES-ACCESSORIES 4 Y

C020399 CARDIAC TISSUE ABLATION DEVICES-OTHER 4 Y

PHONATION VALVES

CODE TERM LEVEL TERMINAL LEVEL

R90 RESPIRATORY AND ANAESTHESIA DEVICES-VARIOUS 2 N

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

R9006 PHONATION VALVES 3 N

R900601 PHONATION VALVES FOR TRACHEOSTOMIC CANNULA 4 Y

R900602 PHONATION VALVES FOR TRACHEOSTOMY 4 Y

R90060201 PHONATORY VALVES FOR TRACHEOSTOMY FOR VENTILATOR USE 5 Y

R90060202 PHONATORY VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE 5 Y

R900680 PHONATION VALVES-ACCESSORIES 4 Y

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

R9099 RESPIRATORY AND ANAESTHESIA DEVICES-OTHER 3 Y

REQUEST:

• DELETE R900601 PHONATION VALVES FOR TRACHEOSTOMICCANNULA

• INSERT R900603-PHONATION VALVES FOR VENTILATOR USE

OUTCOME: PARTIALLYACCEPTED

UROLOGY IMPLANT INSTRUMENTS - REUSABLE

OUTCOME: ACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

L06 UROLOGY INSTRUMENTS, REUSABLE 2 N

L0604 ENDOSCOPIC UROLOGY INSTRUMENTS, REUSABLE 3 N

L0605 NON-ENDOSCOPIC UROLOGY DILATORS AND SPREADERS, REUSABLE 3 N

L0606 NON-ENDOSCOPIC UROLOGY FORCEPS, REUSABLE 3 N

L0607 SUPRAPUBIC ACCESS HANDPIECES, REUSABLE 3 Y

L0608 NON-ENDOSCOPIC URINARY TRACT SURGICAL MANIPULATORS, REUSABLE 3 Y

L0609 UROLOGICAL SURGERY INSTRUMENT KITS, REUSABLE 3 Y

L0610 NON-ENDOSCOPIC UROLOGICAL SURGERY SPATULAS, REUSABLE 3 Y

L0611 NON-ENDOSCOPIC UROLOGY NEEDLES, REUSABLE 3 Y

L0612 UROLOGY PROSTHETIC INSTRUMENTS AND KIT, REUSABLE 3 Y

L0699 UROLOGY INSTRUMENTS, REUSABLE-OTHER 3 Y

REQUEST: INSERT L0612 UROLOGY IMPLANT INSTRUMENTS, REUSABLE

ELECTROSURGERY PADS AND CABLES, REUSABLE

CODE TERM LEVEL TERMINAL LEVEL

L REUSABLE SURGICAL INSTRUMENTS 1 N

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

L18 ELECTROSURGERY INSTRUMENTS, REUSABLE 2 N

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

L1810 ELECTROSURGERY PADS (NEUTRAL ELECTRODES) AND CABLES, REUSABLE 3 N

L181001 ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), REUSABLE 4 Y

L181002 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), REUSABLE 4 Y

L181003 ELECTROSURGERY CONNECTION CABLES, REUSABLE 4 Y

... ... ...

REQUEST: INSERT

• K04-ELECTROSURGERY DEVICES, REUSABLE

• • K04xxxx ELECTROSURGERY PADS (NEUTRAL ELECTRODES) AND CABLES, REUSABLE

OUTCOME: PARTIALLYACCEPTED

ARTHROSCOPIC SURGERY INSTRUMENTS

REQUEST: INSERT

• L1919-ARTHROSCOPIC SURGERY MICROFRACTOR REUSABLE

• L1920-ARTHROSCOPIC SURGERY PUNCH, REUSABLE

• L1921-ARTHROSCOPIC SURGERY CURETTE, REUSABLE

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

L19 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE 2 N

L1901 ARTHROSCOPIC SURGERY DISSECTORS, REUSABLE 3 Y

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

L1904 ARTHROSCOPIC SURGERY FORCEPS AND PUNCHES, REUSABLE 3 Y

... ...

L1909 ARTHROSCOPIC SURGERY SCALPELS, MENISCOTOMES AND KNIVESREUSABLE 3 Y

L1910 ARTHROSCOPIC SURGERY HOOKS, REUSABLE 3 Y

... ...

L1917 ARTHROSCOPY ADAPTERS AND CONNECTORS, REUSABLE 3 Y

L1918 MICROFRACTORS FOR BONE STIMULATION, REUSABLE 3 Y

L1919 ARTHROSCOPIC SURGERY SPOONS AND CURETTES, REUSABLE 3 Y

L1920 ARTHROSCOPIC SURGERY FILESAND RASPS, REUSABLE 3 Y

L1921 ARTHROSCOPIC SURGERY PROBES, REUSABLE 3 Y

L1980 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-ACCESSORIES 3 Y

L1999 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-OTHER 3 Y

UROLOGICAL IMPLANT (NON-PROSTHETIC), FOR RADIATION

REQUEST: INSERT U1401-UROLOGICAL IMPLANT (NON-PROSTHETIC), FOR RADIATION

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

P IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES 2 N

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

P90 IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES-VARIOUS 2 N

P9001 TEMPORARY TISSUE EXPANDERS 3 N

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

P9004 STRUCTURES FILLING, REPLACEMENT AND RECONSTRUCTION DEVICES 3 N

P9005 IMPLANTABLE SPACERS FOR PROTECTION DURING RADIATION THERAPY 3 Y

P9099 IMPLANTABLE PROSTHETIC DEVICES-OTHER 3 N

PREPARED MEDIA IN BOTTLES (BACTERIOLOGY)

REQUEST: INSERT SUBLEVEL FOR NOT DEHYDRATED MEDIA IN BOTTLES

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

W01 REAGENTS 2 N

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

W0104 MICROBIOLOGY (CULTURE) 3 N

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

W010401 BACTERIOLOGY-CULTURE MEDIA 4 N

W01040101 DEHYDRATED CULTURE MEDIA (DCM-BACTERIOLOGY)) 5 N

W01040102 PREPARED MEDIA IN TUBES (BACTERIOLOGY) 5 N

W01040103 PREPARED MEDIA IN BOTTLES (BACTERIOLOGY) 5 N

W0104010306 ALL DEHYDRATED CULTURE MEDIA IN BOTTLES 6 Y

W01040104 PREPARED MEDIA IN PLATES (BACTERIOLOGY) 5 N

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

CANDIDA AURIS

CODE TERM LEVEL TERMINAL LEVEL

W01 REAGENTS 2 N

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

W0105 INFECTIOUS DISEASES 3 N

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

W010506 MYCOLOGY (INFECT. IMMUNOLOGY/NAT) 4 N

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

W01050604 MYCOLOGY-NA REAGENTS 5 N

W0105060401 ASPERGILLUS-NA REAGENTS 6 Y

W0105060402 CANDIDA ALBICANS-NA REAGENTS 6 Y

W0105060403 CRYPTOCOCCUS-NA REAGENTS 6 Y

W0105060404 CANDIDA AURIS-NA REAGENTS 6 Y

W0105060499 MYCOLOGY NA REAGENTS-OTHER 6 Y

REQUEST: INSERT W0105060404 - CANDIDA AURIS-NA REAGENTS

OUTCOME: ACCEPTED

REQUEST: INSERT Y120669-WALKING FRAMES WITH CHAIR, 4 WHEELS, MOTORIZED or Y120669-WALKING FRAMES WITH

CHAIR, 4 WHEELS, POWER-ASSISTED

ROLLATORS

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

Y12 PERSONALMOBILITY DEVICES 2 N

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

Y1206 WALKINGDEVICES, TWO-HANDEDOPERATION 3 N

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

Y120606 WHEELED WALKER 4 Y

Y120609 WALKINGFRAMESWITH CHAIR, 4 WHEELS 4 Y

Y120612 WALKINGTROLLEYS 4 Y

Y120615 POWER ASSISTEDMOBILITY ROLLATORS 4 Y

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

REQUEST: INSERT

• Z12101X-MAGNETOENCEPHALOGRAPHY (MEG) INSTRUMENTS

• • Z12101x01 MAGNETOENCEPHALOGRAPHY (MEG) SYSTEMS

MAGNETOENCEPHALOGRAPHY INSTRUMENTS

25

CODE TERM LEVEL TERMINAL LEVEL

Z12 FUNCTIONALITY EXPLORING AND TREATMENT INSTRUMENTS 2 N

... ...

Z1210 NEUROLOGY AND NEUROSURGERY INSTRUMENTS 3 N

... 4 Y

Z121012 MAGNETOENCEPHALOGRAPHY INSTRUMENTS 4 N

Z12101201 MAGNETOENCEPHALOGRAPHY SYSTEMS 5 Y

Z12101280 MAGNETOENCEPHALOGRAPHY INSTRUMENTS – HARDWARE ACCESSORIES 5 Y

Z12101282 MAGNETOENCEPHALOGRAPHY INSTRUMENTS – SOFTWARE ACCESSORIES 5 Y

Z12101285 MAGNETOENCEPHALOGRAPHY INSTRUMENTS-CONSUMABLES 5 Y

Z12101292 MAGNETOENCEPHALOGRAPHY INSTRUMENTS – MEDICAL DEVICE SOFTWARE 5 Y

Z121090 VARIOUS NEUROLOGIC AND NEUROSURGERY INSTRUMENTS 4 N

OUTCOME: ACCEPTED

TENS INSTRUMENTS (Transcutaneous Electrical Nerve Stimulation)

REQUEST: UPDATE Z120622 from MUSCLE STIMULATORS to MUSCLE AND NERVE STIMULATORS (TENS)

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

Z1206 PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS 3 N

Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) 4 N

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

Z120604 IONTOPHORESIS EQUIPMENT 4 Y

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

Z120622 MUSCLE STIMULATORS 4 Y

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

CODE TERM LEVEL TERMINAL LEVEL

Z1206 PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS 3 N

Z120601 ELECTROTHERAPY EQUIPMENT 4 N

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

Z120604 IONTOPHORESIS EQUIPMENT 4 Y

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

Z120622 MUSCLE STIMULATORS 4 Y

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

RADIOFREQUENCY NEURAL TISSUE ABLATION GENERATORS

CODE TERM LEVEL TERMINAL LEVEL

Z12 INSTRUMENTS FOR FUNCTIONAL EXPLORATIONS AND THERAPEUTIC INTERVENTIONS 2 N

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

Z1210 NEUROLOGY AND NEUROSURGERY INSTRUMENTS 3 N

Z121001 RADIOFREQUENCY NERVOUS TISSUE ABLATION INSTRUMENTS 4 Y

Z121002 NERVOUS SYSTEM MONITORING SYSTEMS 4 Y

Z121003 ELECTROENCEPHALOGRAPHY INSTRUMENTS 4 Y

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

REQUEST: INSERT Z121012-RADIOFREQUENCY NEURAL TISSUE ABLATION GENERATORS

OUTCOME: PARTIALLYACCEPTED

CODE TERM LEVEL TERMINAL LEVEL

Z12 INSTRUMENTS FOR FUNCTIONAL EXPLORATIONS AND THERAPEUTIC INTERVENTIONS 2 N

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

Z1210 NEUROLOGY AND NEUROSURGERY INSTRUMENTS 3 N

Z121001 RADIOFREQUENCY INTRA-CEREBRAL LESION GENERATORS 4 Y

Z121002 NERVOUS SYSTEM MONITORING SYSTEMS 4 Y

Z121003 ELECTROENCEPHALOGRAPHY INSTRUMENTS 4 Y

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