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hCG Pregnancy Rapid Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref FHC-102Ref FHC-202
Identity
- Trade Name
- hCG Pregnancy Rapid Test Cassette EUDAMEDhCG Pregnancy Rapid Test EUDAMED
- Device Name
- hCG Pregnancy Rapid Test Cassette EUDAMEDhCG Pregnancy Rapid Test EUDAMED
- Model / Reference
- FHC-102 EUDAMEDFHC-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983149792 EUDAMED06936983138628 EUDAMED06970277510455 EUDAMED
- Basic UDI-DI
- B-06936983149792 EUDAMEDB-06936983138628 EUDAMEDB-06970277510455 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDIreland 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 Rapid Test Cassette by Hangzhou Alltest 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 Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06936983149792 | Class IVD General | Unknown |
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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 (3)
- EUDAMED eb850e74-ecbd-49b2-89ad-318322d4352d 61 fields · synced Aug 2, 2026
- EUDAMED 15a92bff-f879-46a2-a9e9-eee837ab797e 61 fields · synced Jul 13, 2026
- EUDAMED 779d2382-dcce-429e-add8-3d92ef7fedef 61 fields · synced Aug 2, 2026