Glycated Hemoglobin A1c Control
by Maccura Biotechnology Co., Ltd. EUDAMED
Active
Ref BL2595001, BL2594001, BL2593001, BL2598001, BL2591001, BL2597001, BL2594002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-BL2595001EF | Date22 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Glycated Hemoglobin A1c Control
- Model / Reference
- BL2595001, BL2594001, BL2593001, BL2598001, BL2591001, BL2597001, BL2594002
- Primary DI / UDI-DI
- D-BL2595001EF, D-BL2594001E8, D-BL2593001DZ, D-BL2598001F4, D-BL2591001DK, D-BL2597001EV, D-BL2594002EA
- Basic UDI-DI
- B-BL2595001EF, B-BL2594001E8, B-BL2593001DZ, B-BL2598001F4, B-BL2591001DK, B-BL2597001EV, B-BL2594002EA
- EMDN Code
- W0101050205 Diabetes controls
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Maccura Biotechnology Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No