Knee Orthosis Brace
by Fortune Company Limited EUDAMED
Active
Ref K03a-LGModel K01-UN,K02-XS,K02-SM,K02-MD,K02-LG,K02-XL,K02-2XL,K03a-UN,K03a-SM,K03a-MD,K03a-LG,K04-UN,K05-SM,K05-MD,K05-LG,K06-SM,K06-MD,K06-LG,K06-XL,K12-UN,K15-SM,K15-MD,K15-LG,K15-XL,K16-SM,K16-MD,K16-LG, etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698005810KOBPF | 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- Withdrawn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
- Knee Orthosis Brace
- Model / Reference
- K01-UN, K02-XS, K02-SM, K02-MD, K02-LG, K02-XL, K02-2XL, K03a-UN, K03a-SM, K03a-MD, K03a-LG, K04-UN, K05-SM, K05-MD, K05-LG, K06-SM, K06-MD, K06-LG, K06-XL, K12-UN, K15-SM, K15-MD, K15-LG, K15-XL, K16-SM, K16-MD, K16-LG, etc.
- Primary DI / UDI-DI
- 06980058100119
- Basic UDI-DI
- 698005810KOBPF
- EMDN Code
- Y061209 Knee orthoses
- 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