← Back to catalogue
4K Fluorescence Medical Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref SY-GW1220CModel SY-SHREK-UHD1220Ref SY-GW1210CModel SY-SHREK-UHD1210
Identity
- Trade Name
- 4K Fluorescence Medical Endoscope Camera System EUDAMED
- Device Name
- 4K Fluorescence Medical Endoscope Camera System EUDAMED
- Model / Reference
- SY-SHREK-UHD1220 EUDAMEDSY-GW1220C EUDAMEDSY-SHREK-UHD1210 EUDAMEDSY-GW1210C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975408400124 EUDAMED06975408400117 EUDAMED
- Basic UDI-DI
- 697540840SY-GW1220C00003U EUDAMED697540840SY-GW1210C00003B EUDAMED
- Direct Marketing DI
- 06975408400124 EUDAMED06975408400117 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
4K Fluorescence Medical Endoscope Camera System by Shanghai Shiyin Photoelectric Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED
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-GW1220C00003U | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Shiyin Photoelectric Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000025800
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 347895c1-09b5-4e7c-a0fb-6ab2708624c7 61 fields · synced Oct 6, 2026
- EUDAMED 82dc7d90-26f0-4e0f-8571-db4a8fab4841 61 fields · synced May 18, 2026