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LED Endoscope Cold Light Source
EUDAMEDClass I (EU MDR)
Ref SKS-L21Model S200 Ref SKS-LU11Model S400Ref SKS-L11Model S100Ref SKS-LF11Ref SKS-LU10Ref SKS-L30Model S300 Ref SKS-LF10
Identity
- Trade Name
- LED Endoscope Cold Light Source EUDAMED
- Device Name
- LED Endoscope Cold Light Source EUDAMED
- Model / Reference
- S200 EUDAMEDSKS-L21 EUDAMEDS400 EUDAMEDSKS-LU11 EUDAMEDS100 EUDAMEDSKS-L11 EUDAMEDSKS-LF11 EUDAMEDSKS-LU10 EUDAMEDS300 EUDAMEDSKS-L30 EUDAMEDSKS-LF10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970406 EUDAMED06978385970444 EUDAMED06978385970383 EUDAMED06978385970468 EUDAMED06978385970437 EUDAMED06978385970413 EUDAMED06978385970451 EUDAMED
- Basic UDI-DI
- 697838597S2000000000000NA EUDAMED697838597S4000000000000QU EUDAMED697838597S1000000000000LZ EUDAMED697838597S3000000000000PK EUDAMED
- Direct Marketing DI
- 06978385970406 EUDAMED06978385970444 EUDAMED06978385970383 EUDAMED06978385970468 EUDAMED06978385970437 EUDAMED06978385970413 EUDAMED06978385970451 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 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
Category: Endoscopic light source unit, line-powered
LED Endoscope Cold Light Source by XuZhou SYKERS Photoelectric Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic light source unit, line-powered.
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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 | 697838597S2000000000000NA | Class I | Active |
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Manufacturer
- Manufacturer
- XuZhou SYKERS Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000046799
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (7)
- EUDAMED c8aa6aae-a75e-4d23-96cb-53a5e66fccb3 61 fields · synced Aug 2, 2026
- EUDAMED c24c0ba0-d432-4eda-b902-b3033babb71e 61 fields · synced May 17, 2026
- EUDAMED 029afd89-718c-4cb5-a121-c7dda7bf71ce 61 fields · synced May 17, 2026
- EUDAMED fa324605-df1f-4034-9434-9e8c2c001282 61 fields · synced May 17, 2026
- EUDAMED 056680d5-ecda-4d75-9b88-f8f10d4f7616 61 fields · synced May 18, 2026
- EUDAMED e70008d5-4f88-4a1f-853e-dc64c10ef446 61 fields · synced May 18, 2026
- EUDAMED cbf2f424-f102-4320-84dc-905c17b26362 61 fields · synced May 18, 2026