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EG-580UT - SFDA Registration ME0000000626SFDAA00072

Access comprehensive regulatory information for EG-580UT 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 ME0000000626SFDAA00072 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
ME0000000626SFDAA00072
EG-580UT
SFDA Registration: ME0000000626SFDAA00072
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Product Information

Upper gastrointestinal endoscope

Product Use

Ultrasonic Endoscope EG-580UT is an upper gastrointestinal endoscope intended for the observation and diagnosis of the esophagus, stomach and duodenum, and for the observation, diagnosis and endoscopic treatment of submucosal and peripheral organs at medical facilities under the management of physicians. This product is not intended for use on children and infants. This manual provides necessary information for using the ultrasonic endoscope, such as the equipment overview, operation procedures and precautions to observe. The Reprocessing Manual describes precautions and the cleaning, disinfection and storage methods for the ultrasonic endoscope. If you are a first-time user of this product, be sure to read this manual before actual operation. Also, after reading this manual, store it close to this product for future reference to keep the ultrasonic endoscope in optimum working condition.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000626SFDAA00072
Authorization ID
GHTF-2018-1940
Status
Active
Expire Date
November 21, 2022
Manufacturer
Manufacturer Name
FUJIFILM Corporation
Model Information
Model ID(s)
EG-580UT
Product Accessories

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