Identity
- Trade Name
- NikoClips EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode connector FDA UDI
- Device Name
- NikoClips Adapter Clips EUDAMEDAdapter clip for ECG diagnostic and monitoring electrodes FDA UDI
- Model / Reference
- NIK-20 EUDAMEDFDA UDI
- Description
- Adapter clip for ECG diagnostic and monitoring electrodes FDA UDI
Identifiers
- Catalog Number
- NIK-20 FDA UDI
- Primary DI / UDI-DI
- 10853512006612 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853512006ECGELCTRDCLIPBK EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
- GMDN Term
- Electrocardiographic electrode connector FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NikoClips by Nikomed Usa Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0853512006ECGELCTRDCLIPBK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nikomed Usa Inc
- EUDAMED SRN
- US-MF-000026969
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 9f81f814-94e8-4a7f-a426-a50a423373cb 61 fields · synced Jul 19, 2026
- FDA UDI d3db8fe5-ff00-493a-9b32-bb9a5f9dc80e 34 fields · synced May 30, 2026