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HCG Pregnancy Rapid Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref GAHCG-103d-5T
Identity
- Trade Name
- HCG Pregnancy Rapid Test EUDAMED
- Device Name
- HCG Pregnancy Rapid Test EUDAMED
- Model / Reference
- GAHCG-103d-5T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GAHCG-103d-5TLE EUDAMED
- Basic UDI-DI
- B-GAHCG-103d-5TLE EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HCG Pregnancy Rapid Test by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-GAHCG-103d-5TLE | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 135d81f6-08f3-4fe9-b7bb-f20d5c7dc3a5 61 fields · synced Jun 17, 2026