HDL/LDL Control
Ref HBC10
HDL/LDL Control (HBC10) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category lipid controls) made by Cypress Diagnostics, registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI B-05404035101421), active as of 22 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05404035101421 05404035101421 | Date19 Mar 2026 | StatusActive |
Official records
- EUDAMED public site B-05404035101421
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / reference
- HBC10
- Primary DI / UDI-DI
- 05404035101421
- Basic UDI-DI
- B-05404035101421
- EMDN code
- W0101050202 Lipid controls
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000000033
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