Samekh
by OFF CARR Srl
Ref SAMEKH
Samekh is a Class I device made by OFF CARR Srl, registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI 805390484320DJ), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805390484320DJ 08053904843206 | Date16 Apr 2026 | StatusActive |
Official records
- EUDAMED public site 805390484320DJ
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- Withdrawn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/MDR Active
Specification
- Model / reference
- SAMEKH
- Primary DI / UDI-DI
- 08053904843206
- Basic UDI-DI
- 805390484320DJ
- Direct marketing DI
- 08053904843206
- EMDN code
- Y180939 Modular posture systems
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000024334
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