Swift Posterior Helixband Kit
by Thorwear, Inc (dba Elevate Movement) United States EUDAMED
Ref EAP-0064Model EAP-0XXX EMDN Y061280
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850033914SWIFTZ7 | Date3 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Swift Afo System
- Model / Reference
- EAP-0XXX, EAP-0064
- Primary DI / UDI-DI
- 00850033914085
- Basic UDI-DI
- 0850033914SWIFTZ7
- Direct Marketing DI
- 00850033914085
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000038778
- Authorised representative
- veomedical GmbH DE-AR-000038460
Other devices from Thorwear, Inc (dba Elevate Movement)
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 1ba29c85-37ea-4442-8b02-7ed794694e9b