Identity
- Trade Name
- LED Endoscope Cold Light Source EUDAMED
- Device Name
- LED Endoscope Cold Light Source EUDAMED
- Model / Reference
- S300 EUDAMEDSKS-L31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970420 EUDAMED
- Basic UDI-DI
- 697838597S3000000000000PK EUDAMED
- Direct Marketing DI
- 06978385970420 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
Similar devices
Also classified as Endoscopic light source unit, line-powered.
- Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
- SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
- SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
- LED 610 Light source — Erbe Vision GmbH · Class I
- SPOTLIGHT — Depuy Spine, Inc. · Class II
- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
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 | 697838597S3000000000000PK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- XuZhou SYKERS Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000046799
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 2240ff78-4e98-4ff7-bf12-b59b9c6e9c0d 61 fields · synced Jun 20, 2026