Softpro
by Ongoing Care Solutions, Inc United States EUDAMED
Ref SP2 10-82Model ANKLE FOOT ORTHOSIS
EMDN Y06120601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0849214036206XG | Date5 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- ANKLE FOOT ORTHOSIS, SP2 10-82
- Primary DI / UDI-DI
- 00849214005452
- Basic UDI-DI
- 0849214036206XG
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000048030
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Ongoing Care Solutions, Inc
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED d76bb47b-dc03-49e9-a0f0-0ba87b840eb5