Identity
- Trade Name
- Amadeo EUDAMED
- Device Name
- Amadeo EUDAMEDAmadeo and EMG EUDAMED
- Model / Reference
- R7 EUDAMED10587 EUDAMED15153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120077180212 EUDAMED09120077180205 EUDAMED
- Basic UDI-DI
- 912007718AMADEO3J EUDAMED912007718AMADEO+EMGC8 EUDAMED
- Direct Marketing DI
- 09120077180212 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
- Medical Purpose
- Amadeo is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury. Depending on national variances, Amadeo is typically used in ergotherapy and/or physiotherapy in addition to conventional therapy forms as therapy support, enhancement and intensification. The repetitive movements of finger joints generate intrinsic and extrinsic stimuli that benefit the reorganization of the brain. Repetitive active exercise and training promotes neuronal plasticity and thus the changes (adaptations) of synapses, nerve cells or even entire cerebral areas in order to reclaim lost movements. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Amadeo 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 | 912007718AMADEO3J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tyromotion GmbH
- EUDAMED SRN
- AT-MF-000016168
Sources (2)
- EUDAMED 85c1b3c3-3638-45d1-826b-24a09ed434d0 61 fields · synced Jul 25, 2026
- EUDAMED caf87676-33f2-4c98-aec0-6b0185192b8f 61 fields · synced May 17, 2026