SenSura Click
Ref 10011
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322976028N | Date31 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SenSura Click ostomy baseplate
- Model / Reference
- 10011
- Primary DI / UDI-DI
- 05708932403399, 05708932415583, 05708932369114, 05708932340038, 05708932357302, 05708932358279, 05708932358330, 05708932353519, 05708932355254, 05708932354639, 05708932417754, 05708932338271
- Basic UDI-DI
- 57089322976028N
- Unit of Use DI
- 05701780038232, 05701780038096, 05701780038287, 05708932964845, 05701780038294, 05701780038171, 05701780038065, 05701780038331, 05701780038355, 05701780038362, 05701780038133, 05701780038195
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- Device Class
- Class I
- EU market of registration
- SloveniaCroatiaLiechtensteinGermanyNorwayIrelandBelgiumFinlandNetherlandsDenmarkPortugalItaly
Manufacturer details
- EUDAMED SRN
- DK-MF-000025526
Other devices from Coloplast A/S
Properties
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