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Glycated Hemoglobin Analyzer
EUDAMEDClass A (EU MDR)
Ref G21Model G20, G21, G60, G80 Ref G20, G21
Identity
- Trade Name
- Glycated Hemoglobin Analyzer EUDAMED
- Device Name
- Glycated Hemoglobin Analyzer EUDAMED
- Model / Reference
- G20, G21, G60, G80 EUDAMEDG21 EUDAMEDG20, G21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337852369 EUDAMED
- Basic UDI-DI
- 697233785GHgbA010ME EUDAMEDB-06972337852369 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDNetherlands 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 A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697233785GHgbA010ME | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697233785GHgbA010ME | Class A | 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 (3)
- EUDAMED a06cd039-85a3-4640-9ef8-504cd4fbb309 61 fields · synced Jun 19, 2026
- EUDAMED ac5da537-5e67-4dc7-8aff-507d00242a4b 61 fields · synced May 16, 2026
- EUDAMED ac5da537-5e67-4dc7-8aff-507d00242a4b-1 61 fields · synced Jun 9, 2026