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hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref FHC-U101H
Identity
- Device Name
- hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick EUDAMED
- Model / Reference
- FHC-U101H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983119139 EUDAMED
- Basic UDI-DI
- B-06936983119139 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Lithuania 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 Enhanced Sensitivity Rapid Test Dipstick by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — 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-06936983119139 | Class IVD devices for self-testing | 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 cd34ff80-c697-46ae-b5fb-c3e91497eac8 61 fields · synced Jun 19, 2026