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Fluorescence Medical LED Cold Light Source
EUDAMEDClass I (EU MDR)
Ref SY-GW1210LModel SY-SHREK-1200
Identity
- Trade Name
- Fluorescence Medical LED Cold Light Source EUDAMED
- Device Name
- Fluorescence Medical LED Cold Light Source EUDAMED
- Model / Reference
- SY-SHREK-1200 EUDAMEDSY-GW1210L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975408400131 EUDAMED
- Basic UDI-DI
- 697540840SY-SHREK-120009S EUDAMED
- Direct Marketing DI
- 06975408400131 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Endoscopic light source unit, line-powered
Fluorescence Medical LED Cold Light Source by Shanghai Shiyin Photoelectric Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED
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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 | 697540840SY-SHREK-120009S | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Shiyin Photoelectric Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000025800
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED b2ff8361-c24b-466e-9497-70e7c770ebdd 61 fields · synced Jul 9, 2026