Formfit® Back VS
by Össur Iceland ehf. Iceland EUDAMED
Ref 209122Model BU00038
EMDN Y060308
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00038NJ | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BU00038, 209122
- Primary DI / UDI-DI
- 05690977586994
- Basic UDI-DI
- 5690967BU00038NJ
- EMDN Code
- Y060308 Lumbosacral spine orthoses
- 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 (12)
- Sterile: No
- Implantable: No
- Reusable: 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 05690977586994|5690967BU00038NJ