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Hokapi™ Her-2/Neu
EUDAMEDClass C (EU MDR)
Ref 010123001Ref 010123601Ref 010123101
Identity
- Trade Name
- HOKAPI™ HER-2/NEU EUDAMED
- Device Name
- HOKAPI™ HER-2/NEU EUDAMED
- Model / Reference
- 010123001 EUDAMED010123601 EUDAMED010123101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404717 EUDAMED06939716404724 EUDAMED06971390439746 EUDAMED
- Basic UDI-DI
- 69713904301237K EUDAMED
- Direct Marketing DI
- 06939716404717 EUDAMED06939716404724 EUDAMED06971390439746 EUDAMED
- EMDN Code
- W0102030301 HER-2/NEU EUDAMED
Classification
- Device Class
- Class C 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™ Her-2/Neu 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 | 69713904301237K | 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 349dae74-bac8-41ef-ae2d-5423ec6b3408 61 fields · synced Jul 24, 2026
- EUDAMED 753a3e69-1ca8-46e5-a60b-2f5590f0e9cc 61 fields · synced May 18, 2026
- EUDAMED 6a8c27cf-a11c-4fd9-8ede-c17af5a595a8 61 fields · synced May 19, 2026