Identity
- Trade Name
- HOKAPI™ FPSA EUDAMED
- Device Name
- HOKAPI™ FPSA EUDAMED
- Model / Reference
- 010104601 EUDAMED010104001 EUDAMED010104101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404441 EUDAMED06939716404434 EUDAMED06971390434970 EUDAMED
- Basic UDI-DI
- 69713904301047F EUDAMED
- Direct Marketing DI
- 06939716404441 EUDAMED06939716404434 EUDAMED06971390434970 EUDAMED
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN 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™ Fpsa 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 | 69713904301047F | 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 87771cb8-66ed-41f7-9f74-2edc04c05cad 61 fields · synced Jul 11, 2026
- EUDAMED 6d3b399a-257c-4e9a-9d00-922b7a09790c 61 fields · synced May 18, 2026
- EUDAMED d648106d-9f66-408d-872b-a13cd7f11732 61 fields · synced May 19, 2026