Identity
- Trade Name
- HOKAPI™ AFP EUDAMED
- Device Name
- HOKAPI™ AFP EUDAMED
- Model / Reference
- 010102601 EUDAMED010102001 EUDAMED010102101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404403 EUDAMED06939716404397 EUDAMED06971390439609 EUDAMED
- Basic UDI-DI
- 69713904301027B EUDAMED
- Direct Marketing DI
- 06939716404403 EUDAMED06939716404397 EUDAMED06971390439609 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN 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™ Afp 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 | 69713904301027B | 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 8124ab53-7290-4de9-be5e-a49db124ce9e 61 fields · synced Jul 30, 2026
- EUDAMED feac3783-601c-4fa0-8dce-869137b73943 61 fields · synced May 17, 2026
- EUDAMED 31fbfea2-7c9c-4a77-9d2d-8898f63ff0a9 61 fields · synced May 19, 2026