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Human Chorionic Gonadotropin Rapid Test Kit
EUDAMEDClass B (EU MDR)
Ref G11701Model 25 tests/box
Identity
- Trade Name
- Human Chorionic Gonadotropin Rapid Test Kit EUDAMED
- Device Name
- Human Chorionic Gonadotropin Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG11701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580965 EUDAMED
- Basic UDI-DI
- 697518250G117012S EUDAMED
- Direct Marketing DI
- 06942293580965 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Yes
EUDAMED
Human Chorionic Gonadotropin Rapid Test Kit by Beijing Diagreat Biotechnologies 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 | 697518250G117012S | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 3f6d1253-d2ba-4d2c-bd53-864b0e785a7b 61 fields · synced Jun 19, 2026