Back2Sleep Starter Kit
by BACK2SLEEP EUDAMED
Active
Ref B2SPAC-SK
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3770027709008XX | Date19 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Back2Sleep Kit
- Model / Reference
- B2SPAC-SK
- Primary DI / UDI-DI
- 03770027709008
- Basic UDI-DI
- 3770027709008XX
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class I
- Medical Purpose
- Treatment of Obstructive Sleep Apnea (OSA) and snoring
Manufacturer details
- EUDAMED SRN
- FR-PR-000034641
From the manufacturer
Manufacturer's product page: Size S
Other devices from BACK2SLEEP
Properties
Other properties (1)
- Sterile: No