← Back to catalogue
Glycated Hemoglobin Assay Kit （Fluorescence Immunochromatography）
EUDAMEDClass IVD General (EU MDR)
Ref 50 tests/kit
Identity
- Trade Name
- Glycated Hemoglobin Assay Kit （Fluorescence Immunochromatography） EUDAMED
- Device Name
- Glycated Hemoglobin Assay Kit （Fluorescence Immunochromatography） EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986812374 EUDAMED
- Basic UDI-DI
- B-06974986812374 EUDAMED
- EMDN Code
- W0102019099,W0102060199 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
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
Glycated Hemoglobin Assay Kit （Fluorescence Immunochromatography） by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — CE/MDR — listed in…
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 | B-06974986812374 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1040a5c0-1c96-4364-b415-ca0a940524c6 61 fields · synced Oct 6, 2026