Saudi Arabia SFDA registration ME0000000626SFDAA00084
EN-580T
Saudi Arabia·Medical Device·FUJIFILM Corporation·Class IIaActiveProduct 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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About this record
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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