Identity
- Trade Name
- HOKAPI™ CA 50 EUDAMED
- Device Name
- HOKAPI™ CA 50 EUDAMED
- Model / Reference
- 010108601 EUDAMED010108001 EUDAMED010108101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404526 EUDAMED06939716404519 EUDAMED06971390439647 EUDAMED
- Basic UDI-DI
- 69713904301087P EUDAMED
- Direct Marketing DI
- 06939716404526 EUDAMED06939716404519 EUDAMED06971390439647 EUDAMED
- EMDN Code
- W0102030104 CANCER ANTIGEN 50 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 50 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 | 69713904301087P | 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 f217c6a8-5fda-4d04-b0bf-cf9579eeebbc 61 fields · synced Jul 27, 2026
- EUDAMED ff38c190-3fbb-4bce-9bab-e7cf842c31f5 61 fields · synced May 16, 2026
- EUDAMED a71173eb-42a4-45d8-82c1-6eeaaccb5522 61 fields · synced May 17, 2026