Pure Global

WATCHMANโ„ข Access System - SFDA Registration ME0000000537SFDAA00404

Access comprehensive regulatory information for WATCHMANโ„ข Access System 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 ME0000000537SFDAA00404 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
ME0000000537SFDAA00404
WATCHMANโ„ข Access System
SFDA Registration: ME0000000537SFDAA00404
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Information

Cardiac occluder delivery kit

Product Use

The WATCHMAN Access System is intended to provide vascular and transseptal access for the WATCHMAN Left Atrial Appendage Closure Device with Delivery System.

Device Classification
Risk Class
Class III
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000000537SFDAA00404
Authorization ID
GHTF-2019-3668
Status
Active
Expire Date
May 26, 2024
Manufacturer
Model Information
Model ID(s)
M635TS10060, M635TS20060
Product Accessories

[]