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HbA1c Kit
EUDAMEDClass IVD General (EU MDR)
Ref B35177Model HbA1c Kit 350mLRef B28177Model HbA1c Kit 138mLRef B21172Model HbA1c KitRef B34177Model HbA1c Kit 132mLRef B21176Model HbA1c 585 mLRef B21174Ref B21177Model HbA1c 343 mLRef B29175Model HbA1c+Lyse Kit 520mLRef B21175Model HbA1c 828 mLRef B34175Model HbA1c Kit 264mLRef B21178Model HbA1c 586 mLRef B334176Model HbA1c Kit 248mL
Identity
- Trade Name
- HbA1c Kit EUDAMEDHbA1c EUDAMED
- Device Name
- HbA1c Kit EUDAMEDHbA1c EUDAMEDHbA1c+Lyse Kit EUDAMED
- Model / Reference
- HbA1c Kit 350mL EUDAMEDB35177 EUDAMEDHbA1c Kit 138mL EUDAMEDB28177 EUDAMEDHbA1c Kit EUDAMEDB21172 EUDAMEDHbA1c Kit 132mL EUDAMEDB34177 EUDAMEDHbA1c 585 mL EUDAMEDB21176 EUDAMEDB21174 EUDAMEDHbA1c 343 mL EUDAMEDB21177 EUDAMEDHbA1c+Lyse Kit 520mL EUDAMEDB29175 EUDAMEDHbA1c 828 mL EUDAMEDB21175 EUDAMEDHbA1c Kit 264mL EUDAMEDB34175 EUDAMEDHbA1c 586 mL EUDAMEDB21178 EUDAMEDHbA1c Kit 248mL EUDAMEDB334176 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555617385 EUDAMED08683555618931 EUDAMED08683555625113 EUDAMED08683555616692 EUDAMED08683555610553 EUDAMED08683555625137 EUDAMED08683555610560 EUDAMED08683555614988 EUDAMED08683555610546 EUDAMED08683555616678 EUDAMED08683555610577 EUDAMED08683555616685 EUDAMED
- Basic UDI-DI
- B-08683555617385 EUDAMEDB-08683555618931 EUDAMEDB-08683555625113 EUDAMEDB-08683555616692 EUDAMEDB-08683555610553 EUDAMEDB-08683555625137 EUDAMEDB-08683555610560 EUDAMEDB-08683555614988 EUDAMEDB-08683555610546 EUDAMEDB-08683555616678 EUDAMEDB-08683555610577 EUDAMEDB-08683555616685 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMEDW0103010202 HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1) EUDAMEDW0101070203 GLYCATED HAEMOGLOBIN - ELECTRODES 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-08683555617385 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (12)
- EUDAMED a857f3fb-3557-4f96-965c-93c77280a5b9 61 fields · synced Oct 6, 2026
- EUDAMED d8529193-0907-4290-9eaf-349af6ecd666 61 fields · synced May 11, 2026
- EUDAMED e9551e58-efae-4237-89fb-0291d7b93f79 61 fields · synced May 16, 2026
- EUDAMED 8d26bd07-5c0b-4e4d-be65-b51f2ed3b9ca 61 fields · synced May 17, 2026
- EUDAMED 8b1f411d-a9d0-4287-bc49-fc4ed8c6c8d5 61 fields · synced May 17, 2026
- EUDAMED 3fe7f7c6-3be3-4163-b604-db1a5edbd2f6 61 fields · synced May 17, 2026
- EUDAMED a5e34114-cf2e-4266-8605-a539cba08040 61 fields · synced May 18, 2026
- EUDAMED 36166cfb-df4e-44ab-ac5c-f3036a3c11a1 61 fields · synced May 18, 2026
- EUDAMED 6625f666-6ba8-4329-b206-c183dc1ca3c2 61 fields · synced May 18, 2026
- EUDAMED 093973a5-fb08-4109-805a-cc58ae82ec6f 61 fields · synced May 18, 2026
- EUDAMED 2e9f4f57-726c-4a78-ad8d-21db0c04223e 61 fields · synced May 18, 2026
- EUDAMED 682bd9ec-5b4e-472e-bcad-4d39049a97cc 61 fields · synced May 18, 2026