Spinal Orthosis Brace
by Fortune Company Limited EUDAMED
Active
Ref N01a-2.0Model N01a-2.0,N01a-2.5,N01a-3.0,N01a-3.5,N01a-4.0,N01b-2.0,N01b-2.5,N01b-3.0,N01b-3.5,N01b-4.0,N02-UN,N03-Infant,N03-Child,N03-2.25-SM,N03-2.25-MD,N03-2.25-LG,N03-2.25-XL,N03-3.25-SM,N03-3.25-MD,N03-3.25-LG,N03-3.25-XL, etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698005810SOBQP | 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- Withdrawn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
- Spinal Orthosis Brace
- Model / Reference
- N01a-2.0, N01a-2.5, N01a-3.0, N01a-3.5, N01a-4.0, N01b-2.0, N01b-2.5, N01b-3.0, N01b-3.5, N01b-4.0, N02-UN, N03-Infant, N03-Child, N03-2.25-SM, N03-2.25-MD, N03-2.25-LG, N03-2.25-XL, N03-3.25-SM, N03-3.25-MD, N03-3.25-LG, N03-3.25-XL, etc.
- Primary DI / UDI-DI
- 06980058102298
- Basic UDI-DI
- 698005810SOBQP
- EMDN Code
- Y060399 Spine orthoses - 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