Comfort M2 Cushion
by The Comfort Companies, LLC EUDAMED
Active
Ref M2-FRSA-19W14D
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0194637FMCAU | Date3 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Medical Foam Cushions
- Model / Reference
- M2-FRSA-19W14D
- Primary DI / UDI-DI
- 00194637018740
- Basic UDI-DI
- 0194637FMCAU
- EMDN Code
- V080302 Patient positioning medical cushions
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000032945
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from The Comfort Companies, LLC
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