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Arthrex SynergyID Endoscopic Imaging System - HSA Registration DE0506250

Access comprehensive regulatory information for Arthrex SynergyID Endoscopic Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506250 and owned by Arthrex Inc.,. The device was registered on October 04, 2021.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0506250
Arthrex SynergyID Endoscopic Imaging System
HSA Registration Number: DE0506250
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Product Description

An endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures and procedures within the thoracic cavity. It is also intended to be used as an accessory for microscopic surgery. It is indicated to provide real time endoscopic visible and near-infrared fluorescence imaging. Fluorescence imaging of biliary ducts with the Arthrex SynergyID endoscopic 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 biliary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506250
Registration Date
October 04, 2021
Change Notification Approval Date
January 13, 2025
Retention Due Date
October 03, 2025
Product Owner
Short Name
Arthrex Inc.,
Address
1370 Creekside Boulevard, Naples, FL 34108-1945, USA, UNITED STATES
Registrant
Address
21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
Address
Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model Information
Model Name(s)
SynergyID Console Synergy Laser Light Source 4K SynergyID Camera Head, Autoclavable 4K Laparoscope, 0ยฐ, 10 x 330 mm, NIR 4K Laparoscope, 30ยฐ, 10 x 330 mm, NIR 4K Laparoscope, 45ยฐ, 10 x 333 mm, NIR 4K Laparoscope, 0ยฐ, 5.5 x 300 mm, Hi-Mag, NIR 4K Laparoscope, 30ยฐ, 5.5 x 300 mm, Hi-Mag, NIR 4K Laparoscope, 45ยฐ, 5.5 x 302 mm, Hi-Mag, NIR
Model Identifier(s)
AR-3200-0025 AR-3200-1018 AR-3210-0033 AR-3351-1001 AR-3351-1031 AR-3351-1046 AR-3352-5501 AR-3352-5531 AR-3352-5546