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Hokapi™ D-Dimer
EUDAMEDClass C (EU MDR)
Ref 010714601Ref 010714001Ref 010714401
Identity
- Trade Name
- HOKAPI™ D-DIMER EUDAMED
- Device Name
- HOKAPI™ D-DIMER EUDAMED
- Model / Reference
- 010714601 EUDAMED010714001 EUDAMED010714401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405240 EUDAMED06939716405233 EUDAMED06939716400160 EUDAMED
- Basic UDI-DI
- 693971640714M5 EUDAMED
- Direct Marketing DI
- 06939716405240 EUDAMED06939716405233 EUDAMED06939716400160 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hokapi™ D-Dimer by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class C — 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 | 693971640714M5 | Class C | Active |
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Manufacturer
- Manufacturer
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- EUDAMED SRN
- CN-MF-000013723
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 2abcc0e2-dcf4-42d6-a6f7-300adbd5563c 61 fields · synced Jul 21, 2026
- EUDAMED 6741d8a4-41af-48bb-bbf4-94c959506a6f 61 fields · synced May 18, 2026
- EUDAMED 277c5381-1693-4cc9-94ce-fbb4cad8dd1f 61 fields · synced May 18, 2026