SenSura Click
Ref 10164
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 | Number57089322975138N | 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- Withdrawn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 bag 2-piece closed
- Model / Reference
- 10164
- Primary DI / UDI-DI
- 05708932752275, 05708932374255, 05708932358644, 05708932416818, 05708932374835, 05708932729840, 05708932338813
- Basic UDI-DI
- 57089322975138N
- Unit of Use DI
- 05708932752251, 05701780044905, 05701780045025, 05701780044950, 05701780045018, 05701780422345, 05701780045001
- EMDN Code
- A10020202, A10020302
- Device Class
- Class I
- EU market of registration
- CyprusSlovakiaBelgiumPortugalCzechiaLithuaniaItaly
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