Identity
- Trade Name
- HOKAPI™ HCG EUDAMED
- Device Name
- HOKAPI™ HCG EUDAMED
- Model / Reference
- 010408601 EUDAMED010408101 EUDAMED010408001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716404984 EUDAMED06971390434956 EUDAMED06939716404977 EUDAMED
- Basic UDI-DI
- 697139043040886 EUDAMED
- Direct Marketing DI
- 06939716404984 EUDAMED06971390434956 EUDAMED06939716404977 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN 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™ Hcg 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 | 697139043040886 | 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 92341612-8134-4c59-b724-0c4f40f1917d 61 fields · synced Jul 24, 2026
- EUDAMED 2d062225-cc3b-4fd6-8e43-f1e9c23c75f9 61 fields · synced May 18, 2026
- EUDAMED 7c0f36d0-4f93-4ef5-ab42-43397043f79d 61 fields · synced May 18, 2026