Identity
- Trade Name
- HOKAPI™ CA 125 EUDAMED
- Device Name
- HOKAPI™ CA 125 EUDAMED
- Model / Reference
- 010105101 EUDAMED010105001 EUDAMED010105601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390439616 EUDAMED06939716404458 EUDAMED06939716404465 EUDAMED
- Basic UDI-DI
- 69713904301057H EUDAMED
- Direct Marketing DI
- 06971390439616 EUDAMED06939716404465 EUDAMED
- EMDN Code
- W0102030106 CANCER ANTIGEN 125 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™ Ca 125 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 | 69713904301057H | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
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 e4070350-8707-47ac-93b9-506fe847c54d 61 fields · synced Aug 1, 2026
- EUDAMED 72a084e1-4c97-4b8d-bbe8-e5fb783c7186 61 fields · synced May 17, 2026
- EUDAMED d371fe8f-0009-465d-8e8f-5d5b264ab522 61 fields · synced May 18, 2026