Identity
- Trade Name
- HOKAPI™ CYFRA 21-1 EUDAMED
- Device Name
- HOKAPI™ CYFRA 21-1 EUDAMED
- Model / Reference
- 010110601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404564 EUDAMED
- Basic UDI-DI
- 69713904301107A EUDAMED
- Direct Marketing DI
- 06939716404564 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 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
The HOKAPI CYFRA 21-1 medical device is a Class C standard device that measures the concentration of biomarkers in human tissues. It is designed for use in various clinical and research settings, including oncology and immunotherapy.
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 | 69713904301107A | 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 (1)
- EUDAMED 5fc582df-5f3a-4594-a881-398a93e81f65 61 fields · synced Jul 23, 2026