Walking Boot
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TA601Model TA601,TA602,TA603,TA604,TA605,TA606,TA607,TA608 TA609,TA610,TA611,TA612,TA613,TA614,TA615,TA616 TA617,TA618,TA619,TA620,TA621,TA622,TA623,TA624 TA625,TA626,TA627,TA628,TA629,TA630,TA801,TA802 TA803,TA804
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740WB7K | 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- Withdrawn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
- Walking Boot
- Model / Reference
- TA601, TA602, TA603, TA604, TA605, TA606, TA607, TA608 TA609, TA610, TA611, TA612, TA613, TA614, TA615, TA616 TA617, TA618, TA619, TA620, TA621, TA622, TA623, TA624 TA625, TA626, TA627, TA628, TA629, TA630, TA801, TA802 TA803, TA804
- Primary DI / UDI-DI
- 06977917400008
- Basic UDI-DI
- 697791740WB7K
- EMDN Code
- Y0999 Personal care aids - other
- 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