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century clot
EUDAMEDClass A (EU MDR)
Ref YKCA-2, YKCA-1, YKCA-2V, YKCA-1V, YKCA-2F, YKCA-1F
by ShijiYiKang (Tianjin) Medical Technology Development Co., Ltd.
Identity
- Trade Name
- century clot EUDAMED
- Device Name
- Coagulation & Platelet Function Analyzer EUDAMED
- Model / Reference
- YKCA-2, YKCA-1, YKCA-2V, YKCA-1V, YKCA-2F, YKCA-1F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974020352101 EUDAMED
- Basic UDI-DI
- 697402035YK01GL EUDAMED
- Direct Marketing DI
- 06974020352101 EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
century clot by ShijiYiKang (Tianjin) Medical Technology Development Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697402035YK01GL | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000045976
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (2)
- EUDAMED 0a778eb3-8ad1-443a-8ae9-a5d9ba141be7 61 fields · synced Jul 15, 2026
- EUDAMED 0a778eb3-8ad1-443a-8ae9-a5d9ba141be7-1 61 fields · synced Jun 10, 2026