← Back to catalogue
Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52027008Model 50T/kitRef 52026008Model 25T/kit
Identity
- Device Name
- Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence) EUDAMED
- Model / Reference
- 50T/kit EUDAMED52027008 EUDAMED25T/kit EUDAMED52026008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FA0002YU EUDAMED06950334804543 EUDAMED
- Basic UDI-DI
- B-FA0002YU EUDAMEDB-06950334804543 EUDAMED
- EMDN Code
- W0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-FA0002YU | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 14357852-a367-4505-8cb0-8ba7114ba2ee 61 fields · synced Jul 10, 2026
- EUDAMED b1f5c42a-cef7-43f0-96fc-6959956931ef 61 fields · synced May 17, 2026