Brava
Ref 12011
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322976839G | Date7 Sep 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Brava Adhesive Remover Wipe
- Model / Reference
- 12011
- Primary DI / UDI-DI
- 05708932580762, 05708932068185, 05708932500807, 05708932729574, 05708932545556, 05708932603164, 05708932533720, 05708932511926, 05708932502900, 05708932750455, 05708932728249, 05708932535878, 05708932500760, 05708932500722
- Basic UDI-DI
- 57089322976839G
- Unit of Use DI
- 05708932674096
- EMDN Code
- A108005 Devices for the removal of adhesives from the peristomal skin
- Device Class
- Class I
- EU market of registration
- PortugalHungaryIrelandNetherlandsCzechiaTürkiyeFinlandSpainItalyLiechtensteinEstoniaBelgiumGermanyDenmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000025526
Other devices from Coloplast A/S
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