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LED Light Source
EUDAMEDClass I (EU MDR)
Ref ES-LS100DModel ES-LS100D,ES-LS110D
Identity
- Trade Name
- LED Light Source EUDAMED
- Device Name
- LED Light Source EUDAMED
- Model / Reference
- ES-LS100D,ES-LS110D EUDAMEDES-LS100D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381250107 EUDAMED
- Basic UDI-DI
- 697138125003A85 EUDAMED
- Direct Marketing DI
- 06971381250107 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
Yes
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 Light Source by Scivita Medical 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 | 697138125003A85 | Class I | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ec7b53ca-ff7a-4543-83f1-6061d3b0fd9a 61 fields · synced Jul 9, 2026