knee brace
by Ningbo Tian Yi Gong Mao You Xian Gong Si 2 variants
Ref NC-KB01Model NC-KB02、NC-KB01
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 | Number697765914kn0016A 06977659140514 | Date24 Sep 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- Withdrawn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
- knee brace
- Model / Reference
- NC-KB02、NC-KB01, NC-KB01
- Primary DI / UDI-DI
- 06977659140514
- Basic UDI-DI
- 697765914kn0016A
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- 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