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One Step Pregnancy Test Cassette (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref GAHCG-102bRef GAHCG-102mRef GAHCG-202aRef GAHCG-102d
Identity
- Trade Name
- One Step Pregnancy Test Cassette (Urine) EUDAMEDOne Step Pregnancy Test Cassette (Urine/Serum) EUDAMED
- Device Name
- One Step Pregnancy Test Cassette (Urine) EUDAMEDOne Step Pregnancy Test Cassette (Urine/Serum) EUDAMED
- Model / Reference
- GAHCG-102b EUDAMEDGAHCG-102m EUDAMEDGAHCG-202a EUDAMEDGAHCG-102d EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GAHCG-102bQF EUDAMEDD-GAHCG-102mR5 EUDAMEDD-GAHCG-202aQL EUDAMEDD-GAHCG-102dQK EUDAMED
- Basic UDI-DI
- B-GAHCG-102bQF EUDAMEDB-GAHCG-102mR5 EUDAMEDB-GAHCG-202aQL EUDAMEDB-GAHCG-102dQK 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
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Pregnancy Test Cassette (Urine) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — 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-102bQF | Class IVD General | 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 (4)
- EUDAMED 25de64e0-c4ce-4c73-bacf-935689397c2d 61 fields · synced Oct 6, 2026
- EUDAMED 8d6855a1-6714-4b8b-8535-39625227bb9f 61 fields · synced May 17, 2026
- EUDAMED 38ed27ce-9701-4a3c-abc5-a9963011eff5 61 fields · synced May 18, 2026
- EUDAMED 55f3be1e-6933-40c7-8b21-e9d1b14fa559 61 fields · synced May 18, 2026