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HbA1c+Lyse Kit
EUDAMEDClass IVD General (EU MDR)
Ref B30176Model HbA1c+Lyse Kit 464mLRef B30177Model HbA1c+Lyse Kit 32mLRef B30175Model HbA1c+Lyse Kit 120mL
Identity
- Trade Name
- HbA1c+Lyse Kit EUDAMED
- Device Name
- HbA1c+Lyse Kit EUDAMED
- Model / Reference
- HbA1c+Lyse Kit 464mL EUDAMEDB30176 EUDAMEDHbA1c+Lyse Kit 32mL EUDAMEDB30177 EUDAMEDHbA1c+Lyse Kit 120mL EUDAMEDB30175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555614315 EUDAMED08683555614322 EUDAMED08683555614308 EUDAMED
- Basic UDI-DI
- B-08683555614315 EUDAMEDB-08683555614322 EUDAMEDB-08683555614308 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS 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+Lyse 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-08683555614315 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (3)
- EUDAMED 3a129a28-09a2-4687-8f04-127fb6deb938 61 fields · synced Oct 6, 2026
- EUDAMED c30618fc-8acd-49f0-b087-6598abffd250 61 fields · synced May 18, 2026
- EUDAMED 84e893ac-7802-445e-bb04-a9fecbfd13c9 61 fields · synced May 19, 2026