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SOFTEC Pregnancy Test Kit
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref SFTHCG-C
Identity
- Trade Name
- SOFTEC Pregnancy Test Kit EUDAMED
- Device Name
- SOFTEC Pregnancy Test Kit EUDAMED
- Model / Reference
- SFTHCG-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616084 EUDAMED
- Basic UDI-DI
- B-08697962616084 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SOFTEC Pregnancy Test Kit by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — 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-08697962616084 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED e5fb1649-0d58-46e0-b996-7908b4cfc519 61 fields · synced Jul 19, 2026