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SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab)
EUDAMEDClass IVD General (EU MDR)
Ref ZET01NModel SFSCAGN1
Identity
- Trade Name
- SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab) EUDAMED
- Device Name
- SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab) EUDAMED
- Model / Reference
- SFSCAGN1 EUDAMEDZET01N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616312 EUDAMED
- Basic UDI-DI
- B-08697962616312 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER 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 SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab) 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-08697962616312 | 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 28b2c128-3daf-4c2b-9e04-46a379e0977e 61 fields · synced Oct 6, 2026