Assura
by Coloplast A/S EUDAMED
Active
Ref 2886
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number570893229760994 | Date12 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Assura/Alterna (Original) ostomy baseplate
- Model / Reference
- 2886
- Primary DI / UDI-DI
- 05701780577465, 05701780476263, 05701780080880
- Basic UDI-DI
- 570893229760994
- Unit of Use DI
- 05701780027694, 05701780027663, 05708932965989
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- Device Class
- Class I
- Market of Registration
- IrelandLiechtensteinGermany
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