Elbow Support
Ref 702-BK-XS-1, 724-TAN-L-1, 751CA-BK-F-1, 702-TAN-XXL-1, 668-WT-S-1, 668-BL-L-1, 649-BL-L-1, 603-TAN-XL-1, 603-WT-M-1, 943-TAN-S-1, 943-TAN-XL-1, 953-TAN-XL-1, 943-TAN-L-1, 649-BK-XL-1, 668-BL-XL-1, 702-BL-L-1, 668-BK-M-1, 953-TAN-S-1, 724-BL-L-1, 724-BL-S-1, 724-BL-M-1, 702-TAN-XS-1, 603-WT-S-1, 702-BK-XXL-1, 603-TAN-L-1, 513CP-BK-S-1, 953-TAN-L-1, 649-BL-XXL-1, 751KM-BK-F-1, 702-BK-M-1, 702-BL-XS-1, 702-TAN-M-1, 702-BK-L-1, 649-BK-L-1, 668KM-BK-L-1, 603-TAN-S-1, 513CP-BK-L-1, 702-BL-XL-1, 724-BK-L-1, 702-BL-S-1, 724-BL-XL-1, 953-TAN-M-1, 724-TAN-XL-1, 649-BK-M-1
Active
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 | Number471988489CL103GL | Date4 Sep 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- Withdrawn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
- Upper Extremity Orthoses
- Model / Reference
- 702-BK-XS-1, 724-TAN-L-1, 751CA-BK-F-1, 702-TAN-XXL-1, 668-WT-S-1, 668-BL-L-1, 649-BL-L-1, 603-TAN-XL-1, 603-WT-M-1, 943-TAN-S-1, 943-TAN-XL-1, 953-TAN-XL-1, 943-TAN-L-1, 649-BK-XL-1, 668-BL-XL-1, 702-BL-L-1, 668-BK-M-1, 953-TAN-S-1, 724-BL-L-1, 724-BL-S-1, 724-BL-M-1, 702-TAN-XS-1, 603-WT-S-1, 702-BK-XXL-1, 603-TAN-L-1, 513CP-BK-S-1, 953-TAN-L-1, 649-BL-XXL-1, 751KM-BK-F-1, 702-BK-M-1, 702-BL-XS-1, 702-TAN-M-1, 702-BK-L-1, 649-BK-L-1, 668KM-BK-L-1, 603-TAN-S-1, 513CP-BK-L-1, 702-BL-XL-1, 724-BK-L-1, 702-BL-S-1, 724-BL-XL-1, 953-TAN-M-1, 724-TAN-XL-1, 649-BK-M-1
- Primary DI / UDI-DI
- 04719884895058, 04719884897236, 04719890061669, 04719884895041, 04719884894280, 04719884894334, 04719884893771, 04719884892255, 04719884892224, 04719890060730, 04719890060761, 04719890060969, 04719890060754, 04719884893795, 04719884894365, 04719884894983, 04719884894297, 04719890060938, 04719884897229, 04719884897168, 04719884897199, 04719884895072, 04719884892200, 04719884895065, 04719884892231, 04719890071187, 04719890060952, 04719884893825, 04719890072269, 04719884894945, 04719884894907, 04719884894969, 04719884894976, 04719884893764, 04719890072016, 04719884892194, 04719890071200, 04719884895010, 04719884897212, 04719884894921, 04719884897250, 04719890060945, 04719884897267, 04719884893733
- Basic UDI-DI
- 471988489CL103GL
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- TW-MF-000005197
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Welsheng Corp.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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