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NGENUITY 3D VISUALIZATION SYSTEM - ARCSA Registration 79c1cd056b535bcbd6e0aeef4860cac6

Access comprehensive regulatory information for NGENUITY 3D VISUALIZATION SYSTEM in the Ecuador medical device market through Pure Global AI's free database. This I medical device is registered under ARCSA ID 79c1cd056b535bcbd6e0aeef4860cac6 and manufactured by EMBEDTEK, LLC. The device was registered on October 05, 2021.

This page provides complete registration details including product type (Active), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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ARCSA Official Data
I
79c1cd056b535bcbd6e0aeef4860cac6
NGENUITY 3D VISUALIZATION SYSTEM
ARCSA ID: 79c1cd056b535bcbd6e0aeef4860cac6
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Device Classification
Risk Class
I
Product Type
Active
Commercial Name
Image Processors, Video, for Surgical Microscope
Registration Information
Analysis ID
79c1cd056b535bcbd6e0aeef4860cac6
Registration Date
October 05, 2021
Expiration Date
October 05, 2026
Creation Date
May 10, 2021
Product Use

THE 3D VISUALIZATION SYSTEM NGENUITY™ IS INDICATED TO PROVIDE AUGMENTED STEREOSCOPIC IMAGES OF OBJECTS IN REAL TIME OR FROM RECORDINGS. IT MAY ALSO DISPLAY NON-DIAGNOSTIC INFORMATION FROM VALIDATED ALCON SYSTEMS. THE SYSTEM IS A HIGH-DEFINITION STEREOSCOPIC 3D DIGITAL VIDEO CAMERA AND A WORKSTATION THAT WORKS AS A COMPLEMENT TO THE SURGICAL MICROSCOPE DURING SURGERY, SHOWS IMAGES IN REAL TIME.

Manufacturer
City
WAUKESHA
Country
UNITED STATES
Address
N7W23700 BLUEMOUND RD STE 100. WAUKESHA, WI USA 53188
Product Owner
Name
ALCON LABORATORIES INC.
Country
UNITED STATES
Authorized Representative
Address
AVENIDA AMAZONAS N37-29 AND NATIONAL UNION OF JOURNALISTS. EUROCENTER BUILDING. FLOOR 6
Phone
23933020