Identity
- Trade Name
- KC 4 Delta EUDAMEDKC® 4 Delta FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- KC 4 Delta EUDAMED
- Model / Reference
- N04000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391521421012 EUDAMEDFDA UDI
- Basic UDI-DI
- 53915214KC4UJ EUDAMED
- Direct Marketing DI
- 05391521421012 EUDAMED
- FDA Product Code
- JPA FDA UDI
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 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
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
KC 4 Delta by Tcoag ireland ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 53915214KC4UJ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (2)
- EUDAMED acadb870-8260-45c5-8f1b-fda4276b3cee 61 fields · synced Jul 9, 2026
- FDA UDI 7e1a7306-3a70-4a60-9f41-9f8a4f404c27 32 fields · synced May 30, 2026