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Hokapi™ Ca 15-3
EUDAMEDClass C (EU MDR)
Ref 010107101Ref 010107601Ref 010107001
Identity
- Trade Name
- HOKAPI™ CA 15-3 EUDAMED
- Device Name
- HOKAPI™ CA 15-3 EUDAMED
- Model / Reference
- 010107101 EUDAMED010107601 EUDAMED010107001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390439630 EUDAMED06939716404502 EUDAMED06939716404496 EUDAMED
- Basic UDI-DI
- 69713904301077M EUDAMED
- Direct Marketing DI
- 06971390439630 EUDAMED06939716404502 EUDAMED06939716404496 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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 15-3 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 | 69713904301077M | 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 663b672c-cb29-4660-97a4-ac545be4b88b 61 fields · synced Jul 23, 2026
- EUDAMED eeb1276a-9f0a-4f7d-8949-282a5fed040b 61 fields · synced May 18, 2026
- EUDAMED ef553179-bab3-4071-8221-55dbb617f176 61 fields · synced May 18, 2026