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Hokapi™ Ca 19-9
EUDAMEDClass C (EU MDR)
Ref 010106001Ref 010106601Ref 010106101
Identity
- Trade Name
- HOKAPI™ CA 19-9 EUDAMED
- Device Name
- HOKAPI™ CA 19-9 EUDAMED
- Model / Reference
- 010106001 EUDAMED010106601 EUDAMED010106101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404472 EUDAMED06939716404489 EUDAMED06971390439623 EUDAMED
- Basic UDI-DI
- 69713904301067K EUDAMED
- Direct Marketing DI
- 06939716404489 EUDAMED06971390439623 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 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 19-9 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 | 69713904301067K | 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 ac0885a8-ec88-44d0-89b2-d03b64c72801 61 fields · synced Sep 18, 2026
- EUDAMED 93c30c29-cb8a-4800-b96e-ba4787315fe2 61 fields · synced May 17, 2026
- EUDAMED 4465a7c8-95c6-479a-8443-3b56260c4711 61 fields · synced May 17, 2026