Wrist Splint
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TW001Model TW001,TW002,TW003,TW004,TW005,TW006,TW007,TW008 TW009,TW010,TW011,TW012,TW801,TW802,TW803,TW804, TW805
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740WS8M | 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- Withdrawn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
- Wrist Splint
- Model / Reference
- TW001, TW002, TW003, TW004, TW005, TW006, TW007, TW008 TW009, TW010, TW011, TW012, TW801, TW802, TW803, TW804, TW805
- Primary DI / UDI-DI
- 06977917400497
- Basic UDI-DI
- 697791740WS8M
- EMDN Code
- Y090612 Arm and elbow protections
- 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