SenSura Click
Ref 10041
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- Withdrawn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
- 10041
- Primary DI / UDI-DI
- 05708932424370, 05708932388122, 05708932388207, 05708932399142, 05708932394802, 05708932391184, 05708932417822, 05708932391405, 05708932388061, 05708932387705, 05708932026505
- Basic UDI-DI
- 57089322976028N
- Unit of Use DI
- 05701780041577, 05701780041607, 05701780041621, 05701780041638, 05701780041645, 05701780041492, 05701780041478, 05701780041676, 05701780041591, 05701780041669, 05708932026499
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- Device Class
- Class I
- EU market of registration
- CroatiaNetherlandsDenmarkIrelandBelgiumSlovakiaPortugalItalyLiechtensteinNorwaySlovenia
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