Identity
- Trade Name
- HOKAPI™ PIVKA-II EUDAMED
- Device Name
- HOKAPI™ PIVKA-II EUDAMED
- Model / Reference
- 010125601 EUDAMED010125001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405394 EUDAMED06939716405387 EUDAMED
- Basic UDI-DI
- 693971640125LC EUDAMED
- Direct Marketing DI
- 06939716405394 EUDAMED06939716405387 EUDAMED
- EMDN Code
- W0102039017 PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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™ Pivka-Ii 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 | 693971640125LC | 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 (2)
- EUDAMED 07c95e47-dbcc-44e1-9b6f-887cfe393152 61 fields · synced Jul 9, 2026
- EUDAMED db0635f2-a5e2-4b3c-9d86-7d280540c5dd 61 fields · synced May 18, 2026