Saudi Arabia SFDA registration ME0000000537SFDAA00405
WATCHMAN FLX™
Saudi Arabia·MD·Boston Scientific Corporation·Class IIIActiveProduct information
The WATCHMAN FLX Device is a selfexpanding nitinol structure with a polyethylene terephthalate (PET)
Product use
WATCHMAN FLX is intended for percutaneous, transcatheter closure of the left atrial
appendage
Device classification
- Risk Class
- Class III
- Product Category
- MD
- Product Type
- MD
Registration information
- Registration ID
- ME0000000537SFDAA00405
- Authorization ID
- GHTF-2019-3668
- Status
- Active
- Expire Date
- May 26, 2024
Manufacturer
- Manufacturer Name
- Boston Scientific Corporation
Model information
- Model ID(s)
- M635WS50200 M635WS50240 M635WS50270 M635WS50310 M635WS50350
Product accessories
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About this record
Access comprehensive regulatory information for WATCHMAN FLX™ in the Saudi Arabia medical device market through Pure Global AI's free database. This Class III device is registered with Saudi Arabia SFDA under registration number ME0000000537SFDAA00405 and manufactured by Boston Scientific Corporation.
This page provides complete registration details including product category (MD), 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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