Singapore HSA registration DE0018597
Stryker Neurovascular Wingspan Stent System
Singapore·CLASS D·Stryker Neurovascular·Registered September 26, 2016Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0018597
- Registration Date
- September 26, 2016
- Change Notification Approval Date
- January 18, 2022
- Retention Due Date
- September 25, 2026
Product description
The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients 22 to 80 years old with recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy and due to atherosclerotic disease of intracranial vessels with 70-99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days prior to treatment with the Wingspan Stent System. Patients are eligible for treatment with the Wingspan Stent System if their Modified Rankin Score (mRS) is 3 or less at the time of treatment.
Product Owner
- Short Name
- Stryker Neurovascular
- Address
- 47900 Bayside Parkway, Fremont, CA 94538, UNITED STATES
Registrant
- Address
- 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
- Address
- 47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
- Model Name(s)
- Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System Wingspan Stent System
- Model Identifier(s)
- M003WE0250090 M003WE0250150 M003WE0250200 M003WE0300090 M003WE0300150 M003WE0300200 M003WE0350090 M003WE0350150 M003WE0350200 M003WE0400090 M003WE0400150 M003WE0400200 M003WE0450090 M003WE0450150 M003WE0450200
About this record
Access comprehensive regulatory information for Stryker Neurovascular Wingspan Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0018597 and owned by Stryker Neurovascular. The device was registered on September 26, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D