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SOFTEC Urinalysis Reagent Strips (10 Parameters)
EUDAMEDClass IVD General (EU MDR)
Ref SU10-101
Identity
- Trade Name
- SOFTEC Urinalysis Reagent Strips (10 Parameters) EUDAMED
- Device Name
- SOFTEC Urinalysis Reagent Strips (10 Parameters) EUDAMED
- Model / Reference
- SU10-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962616053 EUDAMED
- Basic UDI-DI
- B-08697962616053 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
SOFTEC Urinalysis Reagent Strips (10 Parameters) 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-08697962616053 | 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 9e9ca32a-def1-4309-b6e2-7f937abb095b 61 fields · synced Jul 11, 2026