Identity
- Trade Name
- Fourier rehab EUDAMED
- Device Name
- Upper limb rehabilitation Equipment（ArmMotus M2 Pro） EUDAMED
- Model / Reference
- M2D02SR、M2D02G EUDAMEDM2D02SR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975010000002 EUDAMED
- Basic UDI-DI
- 697501000VenusXD EUDAMED
- Direct Marketing DI
- 06975010000002 EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 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 | 697501000VenusXD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changsha Fourier Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018147
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 33dc2f4e-329a-4eef-ac1e-72451826ba6e 61 fields · synced Jun 18, 2026