← Back to catalogue
SOFTEC Creatine Kinase-MB Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref SFCKMBModel SFCKMB40
Identity
- Trade Name
- SOFTEC Creatine Kinase-MB Rapid Test Kit EUDAMED
- Device Name
- CK-MB Rapid Test Kit EUDAMED
- Model / Reference
- SFCKMB40 EUDAMEDSFCKMB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616299 EUDAMED
- Basic UDI-DI
- B-08697962616299 EUDAMED
- EMDN Code
- W0102160202 PSA - 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 Creatine Kinase-MB 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-08697962616299 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED 53f03983-a576-4a89-84f6-74d5ee9c8a89 61 fields · synced Jul 20, 2026