Saudi Arabia SFDA registration ME0000000626SFDAA00077
EB-530US
Saudi Arabia·Medical Device·FUJIFILM Corporation·Class IIaActiveProduct 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': ''}]
About this record
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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