Identity
- Trade Name
- HOKAPI™ T4 EUDAMED
- Device Name
- HOKAPI™ T4 EUDAMED
- Model / Reference
- 010305101 EUDAMED010305001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390435328 EUDAMED06939716404816 EUDAMED
- Basic UDI-DI
- 69713904303057T EUDAMED
- Direct Marketing DI
- 06971390435328 EUDAMED06939716404816 EUDAMED
- EMDN Code
- W01020407 THYROXINE EUDAMED
Classification
- Device Class
- Class B 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™ T4 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 | 69713904303057T | 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 (2)
- EUDAMED 5c048a4d-f8b4-4cb3-977f-290845e49126 61 fields · synced Jul 20, 2026
- EUDAMED 112ef2eb-47d5-412a-93cf-c6f6fa17b573 61 fields · synced May 19, 2026