XSEAT light
Ref XSEATLModel Decubitus Therapy Cushion
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 | Number++ECFMXSEATL9P +ECFMXSEATL | Date10 Feb 2022 | 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- Withdrawn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
- XSEAT light
- Model / Reference
- Decubitus Therapy Cushion, XSEATL
- Primary DI / UDI-DI
- +ECFMXSEATL
- Basic UDI-DI
- ++ECFMXSEATL9P
- Direct Marketing DI
- +ECFMXSEATL
- EMDN Code
- V08030102 Non-active anti-decubitus medical cushions
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000007784
Other devices from Funke Medical GmbH
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