Ankle Brace
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TA001Model TA001,TA002,TA003,TA004,TA005,TA006,TA007,TA008 TA009,TA010,TA011,TA012,TA013,TA014,TA015,TA016 TA017,TA018,TA019,TA020,TA021,TA022,TA023,TA801 TA702,TA703,TA704,TA705,TA801,TA802,TA803
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740AB5H | 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- Withdrawn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
- Ankle Brace
- Model / Reference
- TA001, TA002, TA003, TA004, TA005, TA006, TA007, TA008 TA009, TA010, TA011, TA012, TA013, TA014, TA015, TA016 TA017, TA018, TA019, TA020, TA021, TA022, TA023, TA801 TA702, TA703, TA704, TA705, TA801, TA802, TA803
- Primary DI / UDI-DI
- 06977917401197
- Basic UDI-DI
- 697791740AB5H
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- 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