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Glycohemoglobin A1c Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref HbA1c6011Y, HbA1c6012Y, HbA1c6013Y, HbA1c6014Y, HbA1c6015Y, HbA1c6011N, HbA1c6012N, HbA1c6013N, HbA1c6014N, HbA1c6015N
Identity
- Trade Name
- Glycohemoglobin A1c Reagent Kit EUDAMED
- Device Name
- Glycohemoglobin A1c Reagent Kit EUDAMED
- Model / Reference
- HbA1c6011Y, HbA1c6012Y, HbA1c6013Y, HbA1c6014Y, HbA1c6015Y, HbA1c6011N, HbA1c6012N, HbA1c6013N, HbA1c6014N, HbA1c6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HbA1c601Q8 EUDAMED
- Basic UDI-DI
- B-HbA1c601Q8 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Glycohemoglobin A1c Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — 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-HbA1c601Q8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 01d2940d-8de2-4e4c-b29a-b064d49c5ab4 61 fields · synced Jun 19, 2026
- EUDAMED 01d2940d-8de2-4e4c-b29a-b064d49c5ab4-1 61 fields · synced Jun 10, 2026