Back2Sleep
by BACK2SLEEP EUDAMED
Active
Ref B2STUB-MModel Back2Sleep
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number03770027709B2SSILQG | Date25 May 2026 | 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- Withdrawn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
- Nasal airways stent
- Model / Reference
- Back2Sleep, B2STUB-M
- Primary DI / UDI-DI
- 03770027709190
- Basic UDI-DI
- 03770027709B2SSILQG
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000034642
From the manufacturer
Manufacturer's product page: Size S
Other devices from BACK2SLEEP
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No