Identity
- Trade Name
- HOKAPI™ TSH EUDAMED
- Device Name
- HOKAPI™ TSH EUDAMED
- Model / Reference
- 010303101 EUDAMED010303001 EUDAMED010303601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390434864 EUDAMED06939716404779 EUDAMED06939716404786 EUDAMED
- Basic UDI-DI
- 69713904303037P EUDAMED
- Direct Marketing DI
- 06971390434864 EUDAMED06939716404779 EUDAMED06939716404786 EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE 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™ Tsh 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 | 69713904303037P | 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 9b769068-b525-4177-83c5-9a1a735362f6 61 fields · synced Jul 26, 2026
- EUDAMED c967cd70-6b72-466f-afc6-e28254fc93df 61 fields · synced May 17, 2026
- EUDAMED 6c312878-5ade-43d5-91ba-e8c573bebd56 61 fields · synced May 18, 2026