Identity
- Trade Name
- Fourier Rehab EUDAMED
- Device Name
- Lower Limb Gait Rehabilitation Equipment（ExoMotus M4） EUDAMED
- Model / Reference
- M4L02G、M4L02M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975010005090 EUDAMED
- Basic UDI-DI
- 697501000M41HA EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Fourier Rehab by Changsha Fourier Medical Technology Co., Ltd. — Class I — 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 | 697501000M41HA | Class I | Active |
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Manufacturer
- Manufacturer
- Changsha Fourier Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018147
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 1836aa34-42cd-4b33-ab2f-4c8e2a9c3be4 61 fields · synced Jun 18, 2026