Identity
- Trade Name
- Hand Rehabilitation System EUDAMED
- Device Name
- Hand Rehabilitation System EUDAMED
- Model / Reference
- SY-HR12AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973408900576 EUDAMED
- Basic UDI-DI
- 697340890007KN EUDAMED
- Direct Marketing DI
- 06973408900576 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
Hand Rehabilitation System 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 | 697340890007KN | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai SiYi Intelligent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038665
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 04c3be36-4817-4217-96e5-125b5da8609b 61 fields · synced Jun 18, 2026