Neo AMS Wrap OTS
by Össur Iceland ehf. Iceland EUDAMED
Ref B-410000002Model BU00085
EMDN Y061280
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00085NT | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BU00085, B-410000002
- Primary DI / UDI-DI
- 05690977195240
- Basic UDI-DI
- 5690967BU00085NT
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IS-MF-000000173
Other devices from Össur Iceland ehf.
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 8598c78c-2099-42f9-ae09-a86dea7635b6