Upper Limb Brace
by Shijiazhuang aofeite imp&exp co., ltd EUDAMED
Active
Ref T008Model Y001 Y002 Y003 Y006 Y010 Y011 Y012 Y013 Y015 Y020 Y045 Y111 Y201 Y067 Y067-1 Y202 Y123 Y456 Y045-1 S013 Y033 Y108 Y094 Y095 Y0402 Y204 Y096 Y097 Y107 Y024 Y068 Y1202 Y060 Y203 Y205 Y064 Y049 Y044 Y042 Y041 Y039 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69537519LSB01UD | Date7 Nov 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Upper Limb Brace
- Model / Reference
- Y001 Y002 Y003 Y006 Y010 Y011 Y012 Y013 Y015 Y020 Y045 Y111 Y201 Y067 Y067-1 Y202 Y123 Y456 Y045-1 S013 Y033 Y108 Y094 Y095 Y0402 Y204 Y096 Y097 Y107 Y024 Y068 Y1202 Y060 Y203 Y205 Y064 Y049 Y044 Y042 Y041 Y039 etc, T008
- Primary DI / UDI-DI
- 06953759500762
- Basic UDI-DI
- 69537519LSB01UD
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000011825
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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