Cervical Collar
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TN001Model TN001,TN002,TN003,TN004,TN005,TN006,TN007,TN008 TN009,TN010,TN011,TN801,TN802,TN803,TN804
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740CC5R | 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- Withdrawn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
- Cervical Collar
- Model / Reference
- TN001, TN002, TN003, TN004, TN005, TN006, TN007, TN008 TN009, TN010, TN011, TN801, TN802, TN803, TN804
- Primary DI / UDI-DI
- 06977917400343
- Basic UDI-DI
- 697791740CC5R
- EMDN Code
- Y090699 Devices for body protection - 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