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Medical Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref SY-GW1000C-NModel SY-SHREK-7817Ref SY-GW1100C-NModel SY-SHREK-7818Ref SY-GW800C-NModel SY-SHREK-7812
Identity
- Trade Name
- Medical Endoscope Camera System EUDAMED
- Device Name
- Medical Endoscope Camera System EUDAMED
- Model / Reference
- SY-SHREK-7817 EUDAMEDSY-GW1000C-N EUDAMEDSY-SHREK-7818 EUDAMEDSY-GW1100C-N EUDAMEDSY-SHREK-7812 EUDAMEDSY-GW800C-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975408400032 EUDAMED06975408400049 EUDAMED06975408400018 EUDAMED
- Basic UDI-DI
- 697540840SY-SHREK-78171E2 EUDAMED697540840SY-SHREK-78181E5 EUDAMED697540840SY-SHREK-78121DK EUDAMED
- Direct Marketing DI
- 06975408400032 EUDAMED06975408400049 EUDAMED06975408400018 EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS 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
Medical Endoscope Camera System by Shanghai Shiyin Photoelectric Instrument 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 | 697540840SY-SHREK-78171E2 | 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 (3)
- EUDAMED fd6a1431-b905-4f50-8a15-80fb3bafff2a 61 fields · synced Oct 6, 2026
- EUDAMED 963674c0-c040-48c2-8e89-f837453c38a3 61 fields · synced May 16, 2026
- EUDAMED e0be1d2a-348c-41aa-8380-73888c1152b3 61 fields · synced May 17, 2026