X Vario Clutchlock Blackline
by ORTHO-REHA Neuhof GmbH 2 variants
Ref 202B18=4Model 202B18
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 | Number42518119202B18M4 04251811900478 | Date25 Aug 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- Withdrawn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
- X Vario Clutchlock Blackline
- Model / Reference
- 202B18, 202B18=4
- Primary DI / UDI-DI
- 04251811900478
- Basic UDI-DI
- 42518119202B18M4
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000008438
Other devices from ORTHO-REHA Neuhof 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