Lower Limbs brace
by Hengshui Tianjian Medical Supplies Co., Ltd EUDAMED
Active
Ref TJ501Model TJ501,TJ501(1),TJ501(2),TJ501(3), TJ502,TJ502(1),TJ502(2),TJ502(3),TJ502(4), TJ503,TJ504,TJ505,TJ506,TJ506(1),TJ507,TJ508,TJ508(1), TJ508(2),TJ509,TJ510,TJ510(1),TJ601,TJ601(1), TJ602,TJ602(1),TJ603, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697371228LLB001FS | Date11 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Lower Limbs brace
- Model / Reference
- TJ501, TJ501(1), TJ501(2), TJ501(3), TJ502, TJ502(1), TJ502(2), TJ502(3), TJ502(4), TJ503, TJ504, TJ505, TJ506, TJ506(1), TJ507, TJ508, TJ508(1), TJ508(2), TJ509, TJ510, TJ510(1), TJ601, TJ601(1), TJ602, TJ602(1), TJ603, etc
- Primary DI / UDI-DI
- 06973712280944
- Basic UDI-DI
- 697371228LLB001FS
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000016724
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hengshui Tianjian Medical Supplies Co., Ltd.
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