Singapore HSA registration DE0018596

Stryker Neurovascular Surpass™ Streamline™ Flow Diverter

Singapore·CLASS D·Stryker Neurovascular·Registered September 26, 2016

Device classification

Device Class: CLASS D
Medical Speciality Area: Neurology

Registration information

Registration Number: DE0018596
Registration Date: September 26, 2016
Change Notification Approval Date: September 11, 2023
Retention Due Date: September 25, 2026

Product description

The Surpass Streamline Flow Diverter is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤5.3 mm

Product Owner

Name: Stryker Neurovascular
Short Name: Stryker Neurovascular
Address: 47900 Bayside Parkway, Fremont, CA 94538, UNITED STATES

Registrant

Name: STRYKER SINGAPORE PRIVATE LIMITED
Address: 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Importer

Name: DKSH SINGAPORE PTE. LTD. STRYKER SINGAPORE PRIVATE LIMITED TRANSMEDIC PTE LTD
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): Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter Surpass™ Streamline™ Flow Diverter
Model Identifier(s): M003100FPP0 M003101FPP0 M003102FPP0 M003110FPP0 M003111FPP0 M003112FPP0 M003113FPP0 M003114FPP0 M003115FPP0 M003120FPP0 M003121FPP0 M003122FPP0 M003123FPP0 M003124FPP0

About this record

Access comprehensive regulatory information for Stryker Neurovascular Surpass™ Streamline™ Flow Diverter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0018596 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.

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