First Breath Headgear - Medium (M) - Qty 1
by Viomedex Ltd United Kingdom EUDAMED
Ref VX8013 EMDN R0301010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506019576VX80119A | Date13 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- First Breath Headgear
- Model / Reference
- VX8013
- Primary DI / UDI-DI
- 05060195762942
- Basic UDI-DI
- 506019576VX80119A
- EMDN Code
- R0301010401 Cpap helmets and kits
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- GB-MF-000004399
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Viomedex Ltd
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED d98ef276-2fa1-48ba-83d5-972fa7b271bc