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Fourier rehab
EUDAMEDClass IIa (EU MDR)
Ref M1W01MModel M1W01M、M1W01GRef M1W01GRef M3D01URModel M3D01UP、M3D01UN、M3D01URRef M3D01UPRef M2D02GModel M2D02SR、M2D02GRef M1A01MModel M1A01M、M1A01M
Identity
- Trade Name
- Fourier rehab EUDAMED
- Device Name
- Wrist joint rehabilitation Equipment（WristMotus） EUDAMEDUpper limb rehabilitation Equipment（ArmMotus EMU） EUDAMEDUpper limb rehabilitation Equipment（ArmMotus M2 Pro） EUDAMEDAnkle joint rehabilitation Equipment（AnkletMotus） EUDAMED
- Model / Reference
- M1W01M、M1W01G EUDAMEDM1W01M EUDAMEDM1W01G EUDAMEDM3D01UP、M3D01UN、M3D01UR EUDAMEDM3D01UR EUDAMEDM3D01UP EUDAMEDM2D02SR、M2D02G EUDAMEDM2D02G EUDAMEDM1A01M、M1A01M EUDAMEDM1A01M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975010000040 EUDAMED06975010000057 EUDAMED06975010000088 EUDAMED06975010000064 EUDAMED06975010000019 EUDAMED06975010000026 EUDAMED
- Basic UDI-DI
- 697501000M1WKB EUDAMED697501000EMULG EUDAMED697501000VenusXD EUDAMED697501000M1AHX EUDAMED
- Direct Marketing DI
- 06975010000040 EUDAMED06975010000057 EUDAMED06975010000088 EUDAMED06975010000026 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
No
EUDAMEDEUDAMED
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 | 697501000M1WKB | 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 (6)
- EUDAMED c9b90a80-04d6-46b9-a978-99519eb8b85f 61 fields · synced Jul 26, 2026
- EUDAMED 2c174589-c69c-4d2c-ab47-a8cc2ea777db 61 fields · synced May 16, 2026
- EUDAMED 28daf5eb-3ac4-45e4-899c-b4030005f450 61 fields · synced May 17, 2026
- EUDAMED 85d27587-3c92-47a1-ac42-9a750d195bf0 61 fields · synced May 17, 2026
- EUDAMED fdad52df-377d-45cf-929f-1138aefb76eb 61 fields · synced May 18, 2026
- EUDAMED 42fb9a66-3d42-4ad0-ad38-9151f1851d7e 61 fields · synced May 19, 2026