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Near-infrared LED Light Source
EUDAMEDFDA UDIClass I (EU MDR)
Ref LSIR320Model LSIR300 LSIR310 LSIR320 LSIR330Ref LSIR330Ref LSIR300
Identity
- Trade Name
- Near-infrared LED Light Source EUDAMEDFDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- Near-infrared LED Light Source EUDAMEDScivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. Near-Infrared LED Light Source is intended to be used for providing white light and near-infrared light illumination for optical observation or rear camera system of electronic endoscope during endoscopy and endoscopic surgery, not the illumination provided for the human eye to observe the optical endoscope.The product is composed of a control unit and a power cable, without light guide. FDA UDI
- Model / Reference
- LSIR300 LSIR310 LSIR320 LSIR330 EUDAMEDLSIR320 EUDAMEDLSIR330 EUDAMEDFDA UDILSIR300 EUDAMED
- Description
- Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. Near-Infrared LED Light Source is intended to be used for providing white light and near-infrared light illumination for optical observation or rear camera system of electronic endoscope during endoscopy and endoscopic surgery, not the illumination provided for the human eye to observe the optical endoscope.The product is composed of a control unit and a power cable, without light guide. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381250930 EUDAMED06971381250947 EUDAMEDFDA UDI06971381250916 EUDAMED
- Basic UDI-DI
- 697138125014A8D EUDAMED
- Direct Marketing DI
- 06971381250930 EUDAMED06971381250947 EUDAMED06971381250916 EUDAMED
- 510(k) Number
- K221252 FDA UDI
- FDA Product Code
- GCJ FDA UDIIZI FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI892.1600 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic light source unit, line-powered
Near-infrared LED Light Source by Scivita Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic light source unit, line-powered.
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- SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
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- SPOTLIGHT — Depuy Spine, Inc. · Class II
- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697138125014A8D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (4)
- EUDAMED 3dc07d5f-b638-4ef0-b9a0-c2771de19cf8 61 fields · synced Jul 10, 2026
- EUDAMED 7d615dba-2e33-46be-bfeb-96925243d828 61 fields · synced May 16, 2026
- EUDAMED 8c8c261c-e713-4bd9-a7b3-f6fbd67ea77b 61 fields · synced May 19, 2026
- FDA UDI e2939119-492c-4a5f-8fd7-6a44e3e6ffe7 35 fields · synced May 30, 2026