SenSura Mio
by Coloplast A/S Denmark EUDAMED
Ref 11963 EMDN A10020302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number570893229753794 | Date9 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SenSura Mio flex ostomy bag 2-piece open
- Model / Reference
- 11963
- Primary DI / UDI-DI
- 05708932930253, 05708932938648, 05708932920360, 05708932933926
- Basic UDI-DI
- 570893229753794
- Unit of Use DI
- 05708932931045, 05701780081160, 05708932921213, 05708932934824
- EMDN Code
- A10020302 Ileostomy bags for two-part systems, with tissue cover
- Device Class
- Class I
- Market of Registration
- FinlandLiechtensteinIrelandNetherlands
Manufacturer details
- EUDAMED SRN
- DK-MF-000025526
Other devices from Coloplast A/S
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 (4)
- EUDAMED a1b320ba-2d69-4ab6-b1f9-40ecce20563b
- EUDAMED 05708932938648|570893229753794
- EUDAMED 05708932920360|570893229753794
- EUDAMED 05708932933926|570893229753794