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Hokapi™ Gastrin-17
EUDAMEDClass B (EU MDR)
Ref 010124601Ref 010124001Ref 010124101
Identity
- Trade Name
- HOKAPI™ GASTRIN-17 EUDAMED
- Device Name
- HOKAPI™ GASTRIN-17 EUDAMED
- Model / Reference
- 010124601 EUDAMED010124001 EUDAMED010124101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716405431 EUDAMED06939716405424 EUDAMED06939716405417 EUDAMED
- Basic UDI-DI
- 693971640124LA EUDAMED
- Direct Marketing DI
- 06939716405431 EUDAMED06939716405424 EUDAMED06939716405417 EUDAMED
- EMDN Code
- W0102069001 GASTRIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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™ Gastrin-17 by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class B — 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 | 693971640124LA | Class B | 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 592770e9-69ba-4c43-a296-23b648c0e355 61 fields · synced Jul 10, 2026
- EUDAMED 532d9e46-a40d-4a1a-8859-1a7fa545fef3 61 fields · synced May 18, 2026
- EUDAMED 527d4dd2-e62e-42dd-b648-984e488eb40d 61 fields · synced May 18, 2026