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1.5T SENSE GP Flex 8 - SFDA Registration ME0000003238SFDAA00015

Access comprehensive regulatory information for 1.5T SENSE GP Flex 8 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 ME0000003238SFDAA00015 and manufactured by Invivo Corporation.

This page provides complete registration details including product category (Medical Device), 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
ME0000003238SFDAA00015
1.5T SENSE GP Flex 8
SFDA Registration: ME0000003238SFDAA00015
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Product Information

Magnetic Resonance Imaging Coils

Product Use

Used in conjunction with an MR scanner as an accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000003238SFDAA00015
Authorization ID
GHTF-2017-1122
Status
Active
Expire Date
January 13, 2019
Manufacturer
Manufacturer Name
Invivo Corporation
Model Information
Model ID(s)
4535-302-86361
Product Accessories

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