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GLUCOSE Kit
EUDAMEDClass IVD General (EU MDR)
Ref B29165Model GLUCOSE Kit 320mLRef B35166Model GLUCOSE Kit Ref B27165Model GLUCOSE Kit 448mLRef B45165Ref B21165Model Glucose 432 mLRef B33166Model GLUCOSE Kit 240mLRef B35165Model GLUCOSE Kit 250mLRef B22165Model Glucose 230 mL
Identity
- Trade Name
- GLUCOSE Kit EUDAMEDGlucose EUDAMED
- Device Name
- GLUCOSE Kit EUDAMEDGLUCOSE Kit 448mL EUDAMEDGlucose EUDAMED
- Model / Reference
- GLUCOSE Kit 320mL EUDAMEDB29165 EUDAMEDGLUCOSE Kit EUDAMEDB35166 EUDAMEDGLUCOSE Kit 448mL EUDAMEDB27165 EUDAMEDB45165 EUDAMEDGlucose 432 mL EUDAMEDB21165 EUDAMEDGLUCOSE Kit 240mL EUDAMEDB33166 EUDAMEDGLUCOSE Kit 250mL EUDAMEDB35165 EUDAMEDGlucose 230 mL EUDAMEDB22165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555615008 EUDAMED08683555623140 EUDAMED08683555612793 EUDAMED08683555622440 EUDAMED08683555610522 EUDAMED08683555615886 EUDAMED08683555617354 EUDAMED08683555612083 EUDAMED
- Basic UDI-DI
- B-08683555615008 EUDAMEDB-08683555623140 EUDAMEDB-08683555612793 EUDAMEDB-08683555622440 EUDAMEDB-08683555610522 EUDAMEDB-08683555615886 EUDAMEDB-08683555617354 EUDAMEDB-08683555612083 EUDAMED
- EMDN Code
- W01010213 GLUCOSE 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
GLUCOSE 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-08683555615008 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (8)
- EUDAMED 2b62460d-fc15-4986-850f-09f4ad51dee3 61 fields · synced Oct 6, 2026
- EUDAMED c51d4c0d-c096-44a8-99c8-55b0a854965c 61 fields · synced May 17, 2026
- EUDAMED f4af7f10-3067-4812-b10d-8bd59599661d 61 fields · synced May 17, 2026
- EUDAMED 2dcfdeec-8a16-4655-b89b-9c6abbf15fdd 61 fields · synced May 17, 2026
- EUDAMED 771ce7f9-2c47-4618-96f2-8dc3b3309984 61 fields · synced May 18, 2026
- EUDAMED 2d9aff04-4ddd-4e3c-aba2-9f440e187473 61 fields · synced May 18, 2026
- EUDAMED 81166cb1-2cf7-47ca-a528-e205b056a068 61 fields · synced May 18, 2026
- EUDAMED cdd4cfbb-68f3-4f1b-9a34-21f0b4cbecb9 61 fields · synced May 19, 2026