Elbow Brace
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TE001Model TE001,TE002,TE003,TE004,TE005,TE006,TE007,TE008 TE009,TE010,TE011,TE012,TE013,TE014,TE801,TE802 TE803
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740EB5V | 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- Withdrawn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
- Elbow Brace
- Model / Reference
- TE001, TE002, TE003, TE004, TE005, TE006, TE007, TE008 TE009, TE010, TE011, TE012, TE013, TE014, TE801, TE802 TE803
- Primary DI / UDI-DI
- 06977917401500
- Basic UDI-DI
- 697791740EB5V
- 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