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Hand Rehabilitation System
EUDAMEDClass I (EU MDR)
Ref SY-HR12AGRef SY-HR08ERef SY-HR06E
Identity
- Trade Name
- Hand Rehabilitation System EUDAMED
- Device Name
- Hand Rehabilitation System EUDAMED
- Model / Reference
- SY-HR12AG EUDAMEDSY-HR08E EUDAMEDSY-HR06E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973408900569 EUDAMED06973408900446 EUDAMED06973408900422 EUDAMED
- Basic UDI-DI
- 697340890007KN EUDAMED697340890001KA EUDAMED
- Direct Marketing DI
- 06973408900569 EUDAMED06973408900446 EUDAMED06973408900422 EUDAMED
- EMDN Code
- Z120603 PASSIVE REHABILITATIVE GYMNASTICS EQUIPMENT EUDAMEDV0899 MEDICAL SUPPORT EQUIPMENT - OTHER 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 (3)
- EUDAMED 1461e766-73c0-49b2-8419-4299fe5d9da4 61 fields · synced Jul 26, 2026
- EUDAMED f54a8fe7-a4d6-4c30-87c6-221fdc8a9817 61 fields · synced May 18, 2026
- EUDAMED f5c7a412-810f-485a-8925-eee99237eb68 61 fields · synced May 19, 2026