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Endoscopic LED Light Source
EUDAMEDClass I (EU MDR)
Ref 90-630202-00Model SL-200Ref 90-630204-00
Identity
- Trade Name
- Endoscopic LED Light Source EUDAMED
- Device Name
- Endoscopic LED Light Source EUDAMED
- Model / Reference
- SL-200 EUDAMED90-630202-00 EUDAMED90-630204-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973563041015 EUDAMED06973563041022 EUDAMED
- Basic UDI-DI
- 697356304SL-200EH EUDAMED
- Direct Marketing DI
- 06973563041015 EUDAMED06973563041022 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Endoscopic LED Light Source by Shenzhen Sophway Technology 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 | 697356304SL-200EH | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sophway Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027700
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED ae6fdd34-d57f-4e3a-bfed-d3e14f478449 61 fields · synced Aug 3, 2026
- EUDAMED 688c664b-d9a0-48c2-a4ee-fc75eafe255c 61 fields · synced May 18, 2026