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Single Use Balloon Dilator, "MaxPass B-400N-0420" - SFDA Registration ME0000002519SFDAA00133

Access comprehensive regulatory information for Single Use Balloon Dilator, "MaxPass B-400N-0420" 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 ME0000002519SFDAA00133 and manufactured by Olympus Winter & lbe GmbH.

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
ME0000002519SFDAA00133
Single Use Balloon Dilator, "MaxPass B-400N-0420"
SFDA Registration: ME0000002519SFDAA00133
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Product Information

Balloon Dilator

Product Use

This instrument has been designed for for dilating strictures of the biliary tree and the major duodenal papilla during endoscopic applications.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000002519SFDAA00133
Authorization ID
GHTF-2015-0526
Status
Active
Expire Date
August 25, 2020
Manufacturer
Manufacturer Name
Olympus Winter & lbe GmbH
Model Information
Model ID(s)
WA95040A
Product Accessories

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