SenSura Mio
by Coloplast A/S Denmark EUDAMED
Ref 18661 EMDN A1001020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number570893229762796 | Date11 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SenSura Mio High Output ostomy bag 1-piece
- Model / Reference
- 18661
- Primary DI / UDI-DI
- 05708932051415, 05708932051330, 05708932065481, 05708932051736
- Basic UDI-DI
- 570893229762796
- Unit of Use DI
- 05701780152105, 05701780152075, 05701780152136, 05701780152143
- EMDN Code
- A1001020102 One-piece ileostomy bags for non-retracted stoma, flat, with tissue cover
- Device Class
- Class I
- Market of Registration
- NetherlandsBelgiumIrelandDenmark
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 eeb5aca4-5b3b-46e2-8210-5354ad0b104d
- EUDAMED 05708932051330|570893229762796
- EUDAMED 05708932065481|570893229762796
- EUDAMED 05708932051736|570893229762796