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ZINC Kit
EUDAMEDClass IVD General (EU MDR)
Ref B35305Model ZINC Kit 50mLRef B45305Model ZINC Kit 71mLRef B29305Model ZINC Kit 45mLRef B22305Model Zinc Kit 180mLRef B28305Model ZINC Kit 52mLRef B21306Model ZINC Kit Ref B33305
Identity
- Trade Name
- ZINC Kit EUDAMED
- Device Name
- ZINC Kit EUDAMED
- Model / Reference
- ZINC Kit 50mL EUDAMEDB35305 EUDAMEDZINC Kit 71mL EUDAMEDB45305 EUDAMEDZINC Kit 45mL EUDAMEDB29305 EUDAMEDZinc Kit 180mL EUDAMEDB22305 EUDAMEDZINC Kit 52mL EUDAMEDB28305 EUDAMEDZINC Kit EUDAMEDB21306 EUDAMEDB33305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555617682 EUDAMED08683555622709 EUDAMED08683555615343 EUDAMED08683555601230 EUDAMED08683555619358 EUDAMED08683555625380 EUDAMED08683555601636 EUDAMED
- Basic UDI-DI
- B-08683555617682 EUDAMEDB-08683555622709 EUDAMEDB-08683555615343 EUDAMEDB-08683555601230 EUDAMEDB-08683555619358 EUDAMEDB-08683555625380 EUDAMEDB-08683555601636 EUDAMED
- EMDN Code
- W01010233 ZINC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ZINC Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08683555617682 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (7)
- EUDAMED 0e08bc86-ceed-411f-81f9-2744e2511be8 61 fields · synced Oct 6, 2026
- EUDAMED 36e85fae-9b79-487f-820b-cba4cb3dbdc6 61 fields · synced May 16, 2026
- EUDAMED 82209550-9e64-4735-acda-e7f89ecf5939 61 fields · synced May 17, 2026
- EUDAMED 8c709fa8-31ca-44e7-9af6-3ec0118d766b 61 fields · synced May 17, 2026
- EUDAMED 2a64da80-d124-483c-9c66-e55d303899ef 61 fields · synced May 17, 2026
- EUDAMED 10c18e5c-9fc8-4d88-aef8-d4a22dbc6f81 61 fields · synced May 18, 2026
- EUDAMED bfa12543-f342-4250-96ef-416866cb0f1a 61 fields · synced May 19, 2026