Saudi Arabia SFDA registration ME0000002519SFDAA00133
Single Use Balloon Dilator, "MaxPass B-400N-0420"
Saudi Arabia·Medical Device·Olympus Winter & lbe GmbH·Class IIaActiveProduct 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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About this record
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.
Free DatabasePowered by Pure Global AISFDA Official DataClass IIa