Acurable Limited
Ref SA100
Acurable Limited (SA100) is a Class IIa device made by Acurable Limited, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-SA100UR), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-SA100UR D-SA100UR | Date27 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-SA100UR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- SA100
- Primary DI / UDI-DI
- D-SA100UR
- Basic UDI-DI
- B-SA100UR
- EMDN code
- Z12100501 Polysomnographs
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- GB-MF-000010182
- Authorised representative
- Acurable SLU ES-AR-000005145
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