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hCG Pregnancy Enhanced Sensitivity Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref FHC-U102
Identity
- Trade Name
- hCG Pregnancy Enhanced Sensitivity Rapid Test EUDAMED
- Device Name
- hCG Pregnancy Enhanced Sensitivity Rapid Test EUDAMED
- Model / Reference
- FHC-U102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970277510059 EUDAMED
- Basic UDI-DI
- B-06970277510059 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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 Pregnancy Enhanced Sensitivity Rapid Test by Hangzhou Alltest Biotech.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-06970277510059 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a42dd9c9-5835-4178-b2a9-f4343dd8450c 61 fields · synced Jun 18, 2026