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Glycated Hemoglobin Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel G20Model G20, G21, G60, G80
Identity
- Trade Name
- Glycated Hemoglobin Analyzer EUDAMED
- Device Name
- Glycated Hemoglobin Analyzer EUDAMED
- Model / Reference
- G20 EUDAMEDN/A EUDAMEDG20, G21, G60, G80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337851591 EUDAMED
- Basic UDI-DI
- B-06972337851591 EUDAMED697233785GHgbA010ME EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Glycated Hemoglobin Analyzer by B&E Bio-Technology Co., Ltd. — 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-06972337851591 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06972337851591 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 8c7b4759-0b4b-429f-aaef-f1eba1ec2861 61 fields · synced Aug 1, 2026
- EUDAMED 9ad129f9-b470-4937-8fcf-84cd9651a267 61 fields · synced May 19, 2026