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SOFTEC LH Ovulation Rapid Test Midstream
EUDAMEDClass IVD General (EU MDR)
Ref SFTLH-M
Identity
- Trade Name
- SOFTEC LH Ovulation Rapid Test Midstream EUDAMED
- Device Name
- LH Ovulation Rapid Test Midstream EUDAMED
- Model / Reference
- SFTLH-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616190 EUDAMED
- Basic UDI-DI
- B-08697962616190 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SOFTEC LH Ovulation Rapid Test Midstream by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — Class IVD General — 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-08697962616190 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED ea30f2f8-bfa1-4ebb-b1ef-a5a320a2a99b 61 fields · synced Jul 29, 2026