INSERT

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 (refer to the level C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS). According to the structure of nomenclature peripheral devices include devices for neurovascular scope.

INSERT

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 (refer to the existing level C0104020202 PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS). According to the structure of nomenclature peripheral devices include devices for neurovascular scope.

INSERT

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 (refer to C0104020203 EMBOLISATION DEVICES and the bottom level C010402020301 EMBOLISATION COILS). According to the structure of nomenclature peripheral devices include devices for neurovascular scope.

INSERT

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 related bottom levels). According to the structure of nomenclature peripheral guidewires include guidewires for neurovascular scope.

INSERT

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 related bottom levels). According to the structure of nomenclature peripheral guidewires include guidewires for neurovascular scope.

INSERT

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 related bottom levels). According to the structure of nomenclature peripheral devices include devices with neurovascular scope.

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 (refer to 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 (refer to 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 refers to SINGLE- AND BIPOLAR DEVICES. Accessories of single- and bipolar devices can be both single-use and reusable.

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 molded to 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 surgeon that 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.

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.

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 related bottom 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.

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 thorascopy due 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.