SenSura Flex
by Coloplast A/S Denmark EUDAMED
Ref 10106
EMDN A1002010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322976058U | Date13 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SenSura Flex Xpro ostomy baseplate
- Model / Reference
- 10106
- Primary DI / UDI-DI
- 05708932409919, 05701780281454, 05708932409995, 05708932410076, 05708932410014, 05708932409971, 05708932410052, 05708932409957
- Basic UDI-DI
- 57089322976058U
- Unit of Use DI
- 05701780043168, 05701780422338, 05701780043199, 05708932964616, 05701780043069, 05701780043175, 05701780043182, 05701780043083
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- Device Class
- Class I
- Market of Registration
- LiechtensteinSpainIrelandGermanyNorwayDenmarkFinlandNetherlands
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 (8)
- EUDAMED 2e6dd11d-2dec-4329-96cc-5b8f80613fb0
- EUDAMED 05701780281454|57089322976058U
- EUDAMED 05708932409995|57089322976058U
- EUDAMED 05708932410076|57089322976058U
- EUDAMED 05708932410014|57089322976058U
- EUDAMED 05708932409971|57089322976058U
- EUDAMED 05708932410052|57089322976058U
- EUDAMED 05708932409957|57089322976058U