Pure Global

WATCHMAN FLXโ„ข - SFDA Registration ME0000000537SFDAA00405

Access comprehensive regulatory information for WATCHMAN FLXโ„ข 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.

Free Database
Powered by Pure Global AI
SFDA Official Data
Class III
ME0000000537SFDAA00405
WATCHMAN FLXโ„ข
SFDA Registration: ME0000000537SFDAA00405
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product 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
Model Information
Model ID(s)
M635WS50200 M635WS50240 M635WS50270 M635WS50310 M635WS50350
Product Accessories

[]