Stent M
by BACK2SLEEP EUDAMED
Active
Ref B2STUB-M, B2SPAC-MModel Stent M
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3770027709046Y7 | 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- Withdrawn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
- Trade Name
- Stent MBack2Sleep pack M
- Device Name
- Back2Sleep Kit
- Model / Reference
- B2STUB-M, Stent M, B2SPAC-M
- Primary DI / UDI-DI
- 03770027709046, 03770027709053, 03770027709152
- Basic UDI-DI
- 3770027709046Y7, 3770027709053Y4, 3770027709008XX
- Direct Marketing DI
- 03770027709046
- EMDN Code
- Q03010299 Antisnoring and obstructive sleep apnoea devices - other
- Device Class
- Class I
- Market of Registration
- France
- Medical Purpose
- Back2Sleep pack MTreatment of Obstructive Sleep Apnea (OSA) and snoring
Manufacturer details
- EUDAMED SRN
- FR-MF-000034642
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