Saudi Arabia SFDA registration ME0000000626SFDAA00072
EG-580UT
Saudi Arabia·Medical Device·FUJIFILM Corporation·Class IIaActiveProduct 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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About this record
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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