Vita Roll
Ref 88.08
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 | Number8001698F3D07M1I1P058U 08001698088082 | Date13 Feb 2023 | 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- Withdrawn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
- Semicylindrical inflatable cushion suitable for ergonomic sitting and lumbar support
- Model / Reference
- 88.08
- Primary DI / UDI-DI
- 08001698088082
- Basic UDI-DI
- 8001698F3D07M1I1P058U
- Direct Marketing DI
- 08001698088082
- EMDN Code
- V0899 Medical support equipment - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000021280
Other devices from Ledraplastic SpA
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