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SOFTEC Malaria P.f/P.v Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref SFMPFPV
Identity
- Trade Name
- SOFTEC Malaria P.f/P.v Rapid Test Kit EUDAMED
- Device Name
- Malaria P.f/P.v Rapid Test Kit EUDAMED
- Model / Reference
- SFMPFPV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616718 EUDAMED
- Basic UDI-DI
- B-08697962616718 EUDAMED
- EMDN Code
- W0105090401 PLASMODIUM (MALARIA) - 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 Malaria P.f/P.v Rapid Test Kit 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-08697962616718 | 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 b7d9f6ae-cafb-4dc7-b6f8-e24ab37b7bc6 61 fields · synced Jun 19, 2026