Identity
- Trade Name
- FAST CLIP NC-143E EUDAMEDNA FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Electrocardiograph, professional, multichannel EUDAMEDElectrode Clip, Limb, 4/BX FDA UDI
- Model / Reference
- H068A EUDAMEDNC-143E FDA UDI
- Description
- Electrode Clip, Limb, 4/BX FDA UDI
Identifiers
- Catalog Number
- NC-143E FDA UDI
- Primary DI / UDI-DI
- 04931921871355 EUDAMEDFDA UDI
- Basic UDI-DI
- 4931921MD10015BJ EUDAMED
- FDA Product Code
- OLT FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic lead set, reusable
Fast Clip Nc-143e by Nihon Kohden Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4931921MD10015BJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (2)
- EUDAMED 78a39c0e-fa55-4adf-a04e-30cdcbb04811 61 fields · synced Jul 13, 2026
- FDA UDI f98a7ad2-67e3-422d-a47b-efa5a1e33fee 35 fields · synced May 30, 2026