Manual wheelchair
by Raise Medical Industries Inc. 2 variants
Ref C3133Model C3103, C3104, C3106, C3107, C3108, C3109, C3110, C3114, C3122, C3123, C3124, C3125, C3126, C3127, C3128, C3129, etc
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 | Number697583192MW001NS 06975831921180 | Date24 Oct 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- Withdrawn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
- Manual wheelchair
- Model / Reference
- C3103, C3104, C3106, C3107, C3108, C3109, C3110, C3114, C3122, C3123, C3124, C3125, C3126, C3127, C3128, C3129, etc, C3133
- Primary DI / UDI-DI
- 06975831921180
- Basic UDI-DI
- 697583192MW001NS
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000029869
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Raise Medical Industries Inc.
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