SenSura Click
Ref 10031
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- Withdrawn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
- 10031
- Primary DI / UDI-DI
- 05708932415620, 05708932369459, 05708932417808, 05708932358316, 05708932403436, 05708932338394, 05708932340113, 05701780283267, 05708932358378, 05701780177085, 05708932353557, 05708932357425, 05708932354752, 05708932355377, 05708932374675
- Basic UDI-DI
- 57089322976028N
- Unit of Use DI
- 05701780040631, 05701780040440, 05701780040488, 05701780040570, 05701780040549, 05701780040686, 05708932964722, 05701780283281, 05701780040709, 05701780040679, 05701780040792, 05701780040754, 05701780040822, 05701780040839, 05701780040501
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- Device Class
- Class I
- EU market of registration
- CroatiaLiechtensteinPortugalIrelandSloveniaItalyGermanyHungaryBelgiumEstoniaFinlandNorwayDenmarkNetherlandsSlovakia
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