SenSura
by Coloplast A/S Denmark EUDAMED
Ref 11803 EMDN A1001030102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number570893229757296 | Date18 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SenSura urostomy bag 1-piece
- Model / Reference
- 11803
- Primary DI / UDI-DI
- 05708932401456, 05708932455183
- Basic UDI-DI
- 570893229757296
- Unit of Use DI
- 05701780072014, 05701780072120
- EMDN Code
- A1001030102 One-piece urostomy bags for non-retracted stoma, flat, with tissue cover
- Device Class
- Class I
- Market of Registration
- IrelandSlovenia
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 (2)
- EUDAMED 66368d27-3fc8-43ef-bfeb-80c0d9d48903
- EUDAMED 05708932455183|570893229757296