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EN-580T - SFDA Registration ME0000000626SFDAA00084

Access comprehensive regulatory information for EN-580T 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 ME0000000626SFDAA00084 and manufactured by FUJIFILM 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
ME0000000626SFDAA00084
EN-580T
SFDA Registration: ME0000000626SFDAA00084
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Product Information

Medical endoscope intended for diagnosis and Endoscopic treatment of the esophagus

Product Use

This product is a medical endoscope intended for observation, diagnosis and endoscopic treatment of the esophagus, stomach, duodenum, small intestine and large intestine in medical facilities under management of physicians. Do not use this product for any other purpose.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000626SFDAA00084
Authorization ID
GHTF-2018-1942
Status
Active
Expire Date
November 21, 2022
Manufacturer
Manufacturer Name
FUJIFILM Corporation
Model Information
Model ID(s)
EN-580T
Product Accessories

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