← Back to catalogue
Glycated Hemoglobin Analyzer
EUDAMEDClass A (EU MDR)
Ref G60Model G20, G21, G60, G80 Ref G80
Identity
- Device Name
- Glycated Hemoglobin Analyzer EUDAMED
- Model / Reference
- G20, G21, G60, G80 EUDAMEDG60 EUDAMEDG80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337858071 EUDAMED06972337858088 EUDAMED
- Basic UDI-DI
- 697233785GHgbA010ME EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class 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 A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697233785GHgbA010ME | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
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 6b57413b-2dd3-43ee-ba71-113c9b9ef876 61 fields · synced Jul 11, 2026
- EUDAMED 45fa9ecb-e0d6-47cc-a374-6224da98212e 61 fields · synced May 19, 2026