Hemoglobin A1c Analytical Column
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref H-3Model H-3, H-6, H-10
EMDN W0201050285
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB700001843 | Date22 Jan 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- H-3, H-6, H-10
- Primary DI / UDI-DI
- 06903053089005
- Basic UDI-DI
- 69449040AB700001843
- EMDN Code
- W0201050285 High performance liquid chromatography systems - consumables
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 8f711130-5c72-46ae-947f-1341f29bb2ba