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Hokapi™ Estradiol
EUDAMEDClass B (EU MDR)
Ref 010414401Ref 010414601Ref 010414101
Identity
- Trade Name
- HOKAPI™ ESTRADIOL EUDAMED
- Device Name
- HOKAPI™ ESTRADIOL EUDAMED
- Model / Reference
- 010414401 EUDAMED010414601 EUDAMED010414101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971390439838 EUDAMED06939716405066 EUDAMED06971390439845 EUDAMED
- Basic UDI-DI
- 69713904304147Z EUDAMED
- Direct Marketing DI
- 06971390439838 EUDAMED06939716405066 EUDAMED06971390439845 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL 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™ Estradiol 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 | 69713904304147Z | 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 316f9789-77a6-4eac-937c-2e5fcc60d2dd 61 fields · synced Jul 14, 2026
- EUDAMED ad498fb8-c780-4055-b3c4-4c7e801c7381 61 fields · synced May 17, 2026
- EUDAMED 94a5a5d3-e142-4dcc-809a-f3f046936c69 61 fields · synced May 18, 2026