Saudi Arabia SFDA registration ME0000000537SFDAA00404
WATCHMAN™ Access System
Saudi Arabia·MD·Boston Scientific Corporation·Class IIIActiveProduct 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
- Manufacturer Name
- Boston Scientific Corporation
Model information
- Model ID(s)
- M635TS10060, M635TS20060
Product accessories
[]
About this record
Access comprehensive regulatory information for WATCHMAN™ 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.
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