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Medical LED Cold Light Source(SY-GW800L-N)
EUDAMEDClass I (EU MDR)
Ref 006Model SY-SHREK-7718
Identity
- Trade Name
- Medical LED Cold Light Source(SY-GW800L-N) EUDAMED
- Device Name
- Medical LED Cold Light Source EUDAMED
- Model / Reference
- SY-SHREK-7718 EUDAMED006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978593830066 EUDAMED
- Basic UDI-DI
- 697859383SY-SHREK-77188V EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Medical LED Cold Light Source(SY-GW800L-N) by Anhui Shiyin Photoelectric Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697859383SY-SHREK-77188V | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Shiyin Photoelectric Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000048773
- Authorised Representative
- GRZAN GROUP SL ES-AR-000039086
Sources (1)
- EUDAMED 78711513-7199-46ed-8de6-e83b156437c6 61 fields · synced Aug 1, 2026