Brava
Ref 12070
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 | Number57089322976889S | Date23 Jul 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- Withdrawn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 Elastic Tape
- Model / Reference
- 12070
- Primary DI / UDI-DI
- 05708932724067, 05708932725910, 05708932726283, 05708932577335, 05708932576833, 05701780208963, 05708932726306, 05708932615914, 05708932963107, 05708932529198, 05708932608893, 05708932545112, 05708932726153, 05708932705820, 05708932728171, 05708932677837, 05701780174930, 05708932725934, 05708932725996, 05708932726160, 05708932725927, 05708932533652
- Basic UDI-DI
- 57089322976889S
- EMDN Code
- A108001 Rings / bezels / plates for peristomal skin
- Device Class
- Class I
- EU market of registration
- LithuaniaAustriaLiechtensteinSloveniaPortugalSlovakiaDenmarkTürkiyeGermanyNetherlandsSpainCzechiaIrelandBulgariaEstoniaRomaniaHungaryBelgiumCroatiaItalyNorwayFinland
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