Knee Brace
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TK001Model TK001,TK002,TK003,TK004,TK005,TK006,TK007,TK008 TK009,TK010,TK011,TK012,TK013,TK014,TK015,TK016 TK017,TK801,TK802,TK803,TK804,TK805,TK806, TKS01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740KB6F | Date25 Feb 2025 | 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- Withdrawn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
- Knee Brace
- Model / Reference
- TK001, TK002, TK003, TK004, TK005, TK006, TK007, TK008 TK009, TK010, TK011, TK012, TK013, TK014, TK015, TK016 TK017, TK801, TK802, TK803, TK804, TK805, TK806, TKS01
- Primary DI / UDI-DI
- 06977917401678
- Basic UDI-DI
- 697791740KB6F
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045818
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen Twe Orthopedics 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