Alterna
Ref 0421
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 | Number57089322976799R | Date15 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- Withdrawn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
- Ostomy Belt support belt for ostomy bags and platesBrava Belt support belt for ostomy bags and plates
- Model / Reference
- 0421
- Primary DI / UDI-DI
- 05701780927598, 05701780177955, 05708932147897, 05708932641982, 05701780945554
- Basic UDI-DI
- 57089322976799R, 57089322976789P
- Unit of Use DI
- 05701780181785, 05701780181891, 05701780181877
- EMDN Code
- A108006 Abdominal ostomy support belts
- Device Class
- Class I
- EU market of registration
- CroatiaLithuaniaSlovakiaPortugalEstonia
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