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Skull - Mount Patient Tracker - SFDA Registration ME0000000301SFDAA00241

Access comprehensive regulatory information for Skull - Mount Patient Tracker in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000000301SFDAA00241 and manufactured by Medtronic Navigation, Inc..

This page provides complete registration details including product category (MD), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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Class IIa
ME0000000301SFDAA00241
Skull - Mount Patient Tracker
SFDA Registration: ME0000000301SFDAA00241
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Product Information

Patient Tracker

Product Use

The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.

Device Classification
Risk Class
Class IIa
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000000301SFDAA00241
Authorization ID
GHTF-2018-0130
Status
Active
Expire Date
July 08, 2023
Manufacturer
Model Information
Model ID(s)
9735300
Product Accessories

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