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Singapore HSA registration DE0501141

Stryker Neurovascular Flowgate² Balloon Guide Catheter

Singapore flagSingapore·CLASS D·Stryker Neurovascular·Registered January 24, 2018
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0501141
Registration Date
January 24, 2018
Change Notification Approval Date
September 02, 2024
Retention Due Date
January 23, 2026
Product description
FlowGate2 Balloon Guide Catheters are intended for use in facilitating the insertion and guidance of an intravascular catheter into a blood vessel in the neurovascular system, providing temporary vascular occlusion, and serving as a conduit for Retrieval devices.
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)
Flowgate² Balloon Guide Catheter Flowgate² Balloon Guide Catheter
Model Identifier(s)
90485 90495
About this record

Access comprehensive regulatory information for Stryker Neurovascular Flowgate² Balloon Guide Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0501141 and owned by Stryker Neurovascular. The device was registered on January 24, 2018.

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