Identity
- Trade Name
- HbA1c Kit EUDAMED
- Device Name
- HbA1c Kit EUDAMED
- Model / Reference
- HbA1c Kit 511mL EUDAMEDB28175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555618917 EUDAMED
- Basic UDI-DI
- B-08683555618917 EUDAMED
- EMDN Code
- W0103010202 HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1) 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
HbA1c 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-08683555618917 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (1)
- EUDAMED fbf1c89e-8409-4fa8-b356-18661609f7a9 61 fields · synced Jun 19, 2026