HemoCue HbA1c 501 Analyzer
by OSANG Healthcare Co., Ltd South Korea EUDAMED
Ref 405210Model IGM-0026BM, IGM-0026B EMDN W0201060101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number880911590IGM0026BMUN | Date9 Jun 2026 | StatusActive |
| European Union | CE/IVDR | Number880911590IGM0026BMUN | Date9 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device Name
- HemoCue HbA1c 501 Test Cartridge
- Model / Reference
- IGM-0026BM, 405210, IGM-0026B
- Primary DI / UDI-DI
- 08809115902542, 08809115902610
- Basic UDI-DI
- 880911590IGM0026BMUN, B-08809115902610
- Direct Marketing DI
- 0880911590254208809115902610
- EMDN Code
- W0201060101 Glycosilated hemoglobin devices
- Device Class
- Class AClass IVD General
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- KR-MF-000032605
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from OSANG HEALTHCARE Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
Sources (3)
- EUDAMED 1fa784e8-6ee3-458c-a117-a41f12e16fca
- EUDAMED 08809115902610|880911590IGM0026BMUN
- EUDAMED 08809115902610|B-08809115902610