Knee Stabilizer
Ref 709-TAN-XXL-1, 734-BL-L-1, 709-BL-XXL-1, 709-TAN-M-1, 510CP-BK-M-1, 709-TAN-XL-1, 709-BL-S-1, 709-BL-XL-1, 510CP-BK-XXL-1, 734-TAN-XL-1, 734-TAN-M-1, 709-TAN-L-1, 709-TAN-XS-1, 510CP-BK-S-1, 709-BK-XXL-1, 734-BK-XL-1, 510CP-BK-XL-1, 734-TAN-L-1, 734-BK-M-1, 709-BL-M-1, 510CP-BK-L-1, 734-BL-XL-1, 709-BK-XL-1, 709-BL-L-1, 709-TAN-S-1
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 | Number471988489CL102GJ | 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- Withdrawn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
- Lower Extremity Orthoses
- Model / Reference
- 709-TAN-XXL-1, 734-BL-L-1, 709-BL-XXL-1, 709-TAN-M-1, 510CP-BK-M-1, 709-TAN-XL-1, 709-BL-S-1, 709-BL-XL-1, 510CP-BK-XXL-1, 734-TAN-XL-1, 734-TAN-M-1, 709-TAN-L-1, 709-TAN-XS-1, 510CP-BK-S-1, 709-BK-XXL-1, 734-BK-XL-1, 510CP-BK-XL-1, 734-TAN-L-1, 734-BK-M-1, 709-BL-M-1, 510CP-BK-L-1, 734-BL-XL-1, 709-BK-XL-1, 709-BL-L-1, 709-TAN-S-1
- Primary DI / UDI-DI
- 04719884896192, 04719884897953, 04719884896185, 04719884896109, 04719890071149, 04719884896161, 04719884896062, 04719884896154, 04719890071170, 04719884897991, 04719884897939, 04719884896130, 04719884896208, 04719890071132, 04719884896178, 04719884897977, 04719890071163, 04719884897960, 04719884897915, 04719884896093, 04719890071156, 04719884897984, 04719884896147, 04719884896123, 04719884896079
- Basic UDI-DI
- 471988489CL102GJ
- EMDN Code
- Y061299 Lower extremity orthoses - 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 (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