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Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref ICA2225Model 20 tests/kit
Identity
- Device Name
- Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- 20 tests/kit EUDAMEDICA2225 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565400 EUDAMED
- Basic UDI-DI
- B-06974541565400 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay) by Bioteke Corporation (Wuxi) Co., Ltd. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974541565400 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED b512fb2d-4a67-4870-98e2-c220e6505e55 61 fields · synced Jun 19, 2026