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Fourier rehab
EUDAMEDClass IIa (EU MDR)
Ref M3D01UNModel M3D01UP、M3D01UN、M3D01UR
Identity
- Trade Name
- Fourier rehab EUDAMED
- Device Name
- Upper limb rehabilitation Equipment（ArmMotus EMU） EUDAMED
- Model / Reference
- M3D01UP、M3D01UN、M3D01UR EUDAMEDM3D01UN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975010000071 EUDAMED
- Basic UDI-DI
- 697501000EMULG 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
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 | 697501000EMULG | 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 54a19953-aee2-4456-beb3-7d2b3ffc6a77 61 fields · synced Oct 5, 2026