wrist brace
by Ningbo Tian Yi Gong Mao You Xian Gong Si 2 variants
Ref NC-WB05, NC-WB04, NC-WB003Model NC-WB003、NC-WPIN、NC-WB05、NC-WB04
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697765914wb0017S | Date17 Jul 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- wrist brace
- Model / Reference
- NC-WB003、NC-WPIN、NC-WB05、NC-WB04, NC-WB05, NC-WB04, NC-WB003
- Primary DI / UDI-DI
- 06977659140026, 06977659140033, 06977659140002
- Basic UDI-DI
- 697765914wb0017S
- EMDN Code
- Y090612 Arm and elbow protections
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042780
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Ningbo Tian Yi Gong Mao You Xian Gong Si
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