Melior
Ref 135648
Melior (135648) is a Class I device made by Cerner Corporation, registered in EUDAMED on 28 Mar 2024 (Basic UDI-DI 00853023006MeliorC4), active as of 7 Nov 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number00853023006MeliorC4 | Date28 Mar 2024 | StatusActive |
| European Union | CE/MDR | Number00853023006MeliorC4 | Date28 Mar 2024 | StatusActive |
Official records
- EUDAMED public site 00853023006MeliorC4
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- Withdrawn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/MDD, CE/MDR Active
Specification
- Model / reference
- 135648
- Primary DI / UDI-DI
- 00853023006920, 00868541000091
- Basic UDI-DI
- 00853023006MeliorC4, B-00868541000091
- EMDN code
- Z12040182 General medicine diagnosis and monitoring instruments - software accessories
- Device class
- Class I
- Special device type
- Software
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- US-MF-000007215
- Authorised representative
- Oracle Nederland BV NL-AR-000038897
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