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HbA1c Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass IVD General (EU MDR)
Ref /Ref IF5017
Identity
- Trade Name
- HbA1c Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- HbA1c Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- / EUDAMEDIF5017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414702149 EUDAMED06954414792690 EUDAMED
- Basic UDI-DI
- B-06954414702149 EUDAMED695441470214GZ EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Türkiye EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
HbA1c Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06954414702149 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414702149 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED f3847cb9-4ea1-4464-8f93-980dbeb0e2ab 61 fields · synced Sep 17, 2026
- EUDAMED fa294a1c-477e-4cfa-9d3a-8adeb25d0700 61 fields · synced Jul 8, 2026