Identity
- Trade Name
- Low Frequency Massage Device EUDAMED
- Device Name
- Hand Rehabilitation System EUDAMED
- Model / Reference
- SY-TIM01、SY-BS24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973408900743 EUDAMED
- Basic UDI-DI
- 697340890001KA EUDAMED
- Direct Marketing DI
- 06973408900743 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
Low Frequency Massage Device 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 | 697340890001KA | 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 90afcb00-fa32-4f40-bef9-7c456f18c63c 61 fields · synced Aug 2, 2026