Identity
- Trade Name
- Soft Exoskeleton For Walking EUDAMED
- Device Name
- Upper Limb Intelligent Rehabilitation Training And Evaluation System EUDAMED
- Model / Reference
- SY-EW02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973408900750 EUDAMED
- Basic UDI-DI
- 697340890006KL EUDAMED
- Direct Marketing DI
- 06973408900750 EUDAMED
- EMDN Code
- Z120603 PASSIVE REHABILITATIVE GYMNASTICS EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Soft Exoskeleton For Walking by Shanghai SiYi Intelligent 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 | 697340890006KL | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai SiYi Intelligent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038665
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1d780182-7ee4-4914-bed4-6cb561084c39 61 fields · synced Jul 24, 2026