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hCG One Step Pregnancy Test
EUDAMEDFDA 510(k)Class IVD devices for self-testing (EU MDR)
Ref Strip,Cassette,Midstream510(k) K212447
Identity
- Trade Name
- hCG One Step Pregnancy Test EUDAMED
- Model / Reference
- Strip,Cassette,Midstream EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663982061 EUDAMED
- Basic UDI-DI
- B-06939663982061 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
hCG One Step Pregnancy Test by Sejoy Biomedical Co., Ltd. — Class IVD devices for self-testing — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212447 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-06939663982061 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- FDA Applicant
- Hangzhou Sejoy Electronics & Instruments Co., Ltd.
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 56293fdd-b007-4e51-884a-89ca27d1bf24 85 fields · synced Jul 17, 2026
- EUDAMED 56293fdd-b007-4e51-884a-89ca27d1bf24-1 61 fields · synced Jun 10, 2026
- FDA 510(k) K212447 1 fields · synced May 18, 2026