Shoulder Brace
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TS001Model TS001,TS002,TS003,TS004,TS005,TS006,TS007,TS008 TS009,TS010,TS011,TS012,TS013,TS014,TS015,TS016 TS017,TS018,TS801,TS802,TS803,TS804,TS805
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740SB77 | 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- Withdrawn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
- Shoulder Brace
- Model / Reference
- TS001, TS002, TS003, TS004, TS005, TS006, TS007, TS008 TS009, TS010, TS011, TS012, TS013, TS014, TS015, TS016 TS017, TS018, TS801, TS802, TS803, TS804, TS805
- Primary DI / UDI-DI
- 06977917400961
- Basic UDI-DI
- 697791740SB77
- EMDN Code
- Y060621 Shoulder 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