Omego 1
Omego 1 is a Class I device made by tyromotion GmbH, registered in EUDAMED and listed in FDA GUDID since 18 Sep 2022 (UDI-DI 09120077180083), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number09120077180083 | Date18 Sep 2022 | StatusListed |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 09120077180083
Across registries
- EUDAMED Active
- FDA GUDID UDI-DI 09120077180083 listed 18 Sep 2022 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Omego
- Generic name
- Treadmill/elliptical gait rehabilitation system
- Model / reference
- 1
- Primary DI / UDI-DI
- 09120077180083
- FDA product code
- BXB
- GMDN term
- Treadmill/elliptical gait rehabilitation system
- Device class
- Class I
- Regulation number
- 890.5380
- GUDID distribution status
- In Commercial Distribution
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