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hCG One Step Ultra Pregnancy Test Device (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref FHC-U102
Identity
- Device Name
- hCG One Step Ultra Pregnancy Test Device (Urine) EUDAMED
- Model / Reference
- FHC-U102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FHC-U1028M EUDAMED
- Basic UDI-DI
- B-FHC-U1028M EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
hCG One Step Ultra Pregnancy Test Device (Urine) by Abon Biopharm(Hangzhou) Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-FHC-U1028M | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Abon Biopharm(Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000009171
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 699ddfd3-e07d-4bbc-88b4-53eb3c182f45 61 fields · synced Jul 13, 2026