Upper Extremity Orthosis Brace
by Fortune Company Limited EUDAMED
Active
Ref W24a-UN-LTModel E02-UN,E03-UN,E05-SM,E05-MD,E05-LG,E06-UN,E08-UN,E10-UN,E10-SM,E10-MD,E10-LG,E11-UN,E17-UN,E18-UN,E20-UN,E22-UN-LT,E22-UN-RT,E36-UN,E37-UN,E38-UN,W01-UN,W02-UN-LT,W02-UN-RT,W03-SM-LT,W03-MD-LT,W03-LG-LT,W03-SM-RT, etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698005810UEOBKF | Date13 Jul 2026 | 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- Withdrawn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
- Upper Extremity Orthosis Brace
- Model / Reference
- E02-UN, E03-UN, E05-SM, E05-MD, E05-LG, E06-UN, E08-UN, E10-UN, E10-SM, E10-MD, E10-LG, E11-UN, E17-UN, E18-UN, E20-UN, E22-UN-LT, E22-UN-RT, E36-UN, E37-UN, E38-UN, W01-UN, W02-UN-LT, W02-UN-RT, W03-SM-LT, W03-MD-LT, W03-LG-LT, W03-SM-RT, etc., W24a-UN-LT
- Primary DI / UDI-DI
- 06980058103851
- Basic UDI-DI
- 698005810UEOBKF
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000023028
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Fortune Company 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