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CREATININE Kit
EUDAMEDClass IVD General (EU MDR)
Ref B35121Model CREATININE Kit 440mLRef B21125Model Creatinine 432 mLRef B30120Model CREATININE Kit 420mL Ref B45120Model CREATININE Kit Ref B29121Model CREATININE Kit 225mLRef B45121Ref B34126Model CREATININE Kit 264mLRef B35120Model CREATININE Kit 180mL
Identity
- Trade Name
- CREATININE Kit EUDAMEDCreatinine EUDAMED
- Device Name
- CREATININE Kit EUDAMEDCreatinine EUDAMED
- Model / Reference
- CREATININE Kit 440mL EUDAMEDB35121 EUDAMEDCreatinine 432 mL EUDAMEDB21125 EUDAMEDCREATININE Kit 420mL EUDAMEDB30120 EUDAMEDCREATININE Kit EUDAMEDB45120 EUDAMEDCREATININE Kit 225mL EUDAMEDB29121 EUDAMEDB45121 EUDAMEDCREATININE Kit 264mL EUDAMEDB34126 EUDAMEDCREATININE Kit 180mL EUDAMEDB35120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555617286 EUDAMED08683555610447 EUDAMED08683555601421 EUDAMED08683555622372 EUDAMED08683555614964 EUDAMED08683555622389 EUDAMED08683555616593 EUDAMED08683555617279 EUDAMED
- Basic UDI-DI
- B-08683555617286 EUDAMEDB-08683555610447 EUDAMEDB-08683555601421 EUDAMEDB-08683555622372 EUDAMEDB-08683555614964 EUDAMEDB-08683555622389 EUDAMEDB-08683555616593 EUDAMEDB-08683555617279 EUDAMED
- EMDN Code
- W01010207 CREATININE 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
CREATININE 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-08683555617286 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (8)
- EUDAMED 0b7c0025-8d55-486a-bebc-48c1eb436680 61 fields · synced Oct 5, 2026
- EUDAMED ec1d26d3-a20e-43f9-8395-d21d256f46d7 61 fields · synced May 16, 2026
- EUDAMED ff1a9446-dded-4d8c-b6bb-918dfa23655e 61 fields · synced May 17, 2026
- EUDAMED 3be2b87c-f085-41b0-a05e-93f3de0e5e82 61 fields · synced May 17, 2026
- EUDAMED fa8c9a75-8a6f-401e-bf23-6e554bbfa5e1 61 fields · synced May 18, 2026
- EUDAMED 050f2faa-1d17-40df-b030-df08c77445d9 61 fields · synced May 18, 2026
- EUDAMED 6346ffc6-4b3c-4570-8e41-79068b02ca7c 61 fields · synced May 18, 2026
- EUDAMED aeddd76d-0697-47eb-9ea9-2d900da296b9 61 fields · synced May 19, 2026