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SOFTEC Syphilis Rapid Test Kit (Cassette)
EUDAMEDClass IVD General (EU MDR)
Ref SFSPRTModel SFSPRT40
Identity
- Trade Name
- SOFTEC Syphilis Rapid Test Kit (Cassette) EUDAMED
- Device Name
- Syphilis Rapid Test Kit (Cassette) EUDAMED
- Model / Reference
- SFSPRT40 EUDAMEDSFSPRT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616350 EUDAMED
- Basic UDI-DI
- B-08697962616350 EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - 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 Syphilis Rapid Test Kit (Cassette) 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-08697962616350 | 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 37798c19-2ba6-4cce-be5f-4896e295444b 61 fields · synced Jul 13, 2026