SenSura Flex
by Coloplast A/S Denmark EUDAMED
Ref 113010
EMDN A1002010402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322976068W | Date17 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SenSura Flex ostomy baseplate convex
- Model / Reference
- 113010
- Primary DI / UDI-DI
- 05708932347174, 05708932346535, 05708932350600
- Basic UDI-DI
- 57089322976068W
- Unit of Use DI
- 05701780064330, 05701780064309, 05701780064521
- EMDN Code
- A1002010402 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with introflex stoma
- Device Class
- Class I
- Market of Registration
- SwedenAustriaFrance
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 (3)
- EUDAMED d9f6db8a-334f-4096-801d-62f1ea74fe20
- EUDAMED 05708932346535|57089322976068W
- EUDAMED 05708932350600|57089322976068W