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EB-530US - SFDA Registration ME0000000626SFDAA00077

Access comprehensive regulatory information for EB-530US 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 ME0000000626SFDAA00077 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
ME0000000626SFDAA00077
EB-530US
SFDA Registration: ME0000000626SFDAA00077
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Product Information

Ultrasonic Endoscope for treatment of tracheae and bronchi

Product Use

This product is a medical Ultrasonic Endoscope to be used under the control of doctors in medical facilities for the observation, diagnosis and medical treatment of tracheae and bronchi, as well as the inspection of tracheae, bronchi and adjacent organs, using ultrasonic imaging. Never use this product for any other purpose.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000626SFDAA00077
Authorization ID
GHTF-2018-1940
Status
Active
Expire Date
November 21, 2022
Manufacturer
Manufacturer Name
FUJIFILM Corporation
Model Information
Model ID(s)
EB-530US
Product Accessories

[{'tradeName': 'B20BU', 'description': None, 'gmdn': ''}]