Identity
- Trade Name
- Omego Plus EUDAMED
- Device Name
- Omego Plus EUDAMED
- Model / Reference
- G1 EUDAMED12238 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120077180199 EUDAMED
- Basic UDI-DI
- 912007718OMEGOPlusT4 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The Omego is a robotic device intended for the rehabilitation of patients with impaired lower extremity function. The impairments of the patient target group may result from neurological indications, such as stroke and brain injury. The intended user (operator) must have basic medical training (e.g. physiotherapy or occupational therapy) and experience in conventional therapy. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Omego Plus by tyromotion GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 912007718OMEGOPlusT4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tyromotion GmbH
- EUDAMED SRN
- AT-PR-000036856
Sources (1)
- EUDAMED 015cbfa9-95f9-4814-87ac-93cb065217ba 61 fields · synced Jul 12, 2026