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Pregnancy (hCG) Rapid Test Midstream
EUDAMEDFDA UDIClass IVD devices for self-testing (EU MDR)
Ref FHC-103H
Identity
- Trade Name
- Pregnancy (hCG) Rapid Test Midstream EUDAMEDFDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pregnancy (hCG) Rapid Test Midstream EUDAMEDFDA UDI
- Model / Reference
- FHC-103H EUDAMEDFDA UDI
- Description
- Pregnancy (hCG) Rapid Test Midstream FDA UDI
Identifiers
- Catalog Number
- FHC-103H FDA UDI
- Primary DI / UDI-DI
- 06970277512404 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970277512404 EUDAMED
- FDA Product Code
- LCX FDA UDI
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pregnancy (hCG) Rapid Test Midstream by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06970277512404 | Class IVD devices for self-testing | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD devices for self-testing | Pending data |
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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 (2)
- EUDAMED 135671b3-65fe-490f-925c-a13750dc2449 61 fields · synced Jul 20, 2026
- FDA UDI e0937480-b883-406f-bc4c-35e54b8a35a4 34 fields · synced May 30, 2026