Singapore HSA registration DE0016743
Stryker Neurovascular TransForm® Occlusion Balloon Catheter
Singapore·CLASS D·Stryker Neurovascular·Registered January 16, 2015Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
- HSA Product Code
- HSAMDD00110
- HS Code
- 90183990
Registration information
- Registration Number
- DE0016743
- Registration Date
- January 16, 2015
- Change Notification Approval Date
- September 11, 2023
- Retention Due Date
- January 15, 2026
Product description
The Stryker Neurovascular TransForm Occlusion Balloon Catheter is indicated for use in the neurovasculature to temporarily stop or control blood flow, for balloon-assisted coil embolization of intracranial aneurysms, and as an adjunct to the medical management of vasospasms or the treatment of refractory symptomatic cerebral vasospasms. The Stryker Neurovascular TransForm Occlusion Balloon Catheter is indicated for use in the peripheral vasculature to temporarily stop or control blood flow, and for balloon-assisted coil embolization of aneurysms.
Product Owner
- Short Name
- Stryker Neurovascular
- Address
- 47900 Bayside Parkway, Fremont, CA 94538-6515, 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)
- TransForm™ C COMPLIANT Occlusion Balloon Catheter 3mm x 10mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 3mm x 15mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 4mm x 10mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 4mm x 15mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 4mm x 20mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 4mm x 30mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 5mm x 10mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 5mm x 15mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 5mm x 20mm TransForm™ C COMPLIANT Occlusion Balloon Catheter 5mm x 30mm TransForm™ SC SUPER COMPLIANT Occlusion Balloon Catheter 3mm x 5mm TransForm™ SC SUPER COMPLIANT Occlusion Balloon Catheter 4mm x 7mm TransForm™ SC SUPER COMPLIANT Occlusion Balloon Catheter 4mm x 10mm TransForm™ SC SUPER COMPLIANT Occlusion Balloon Catheter 7mm x 7mm TransForm™ SC SUPER COMPLIANT Occlusion Balloon Catheter 7mm x 10mm TransForm™ SC SUPER COMPLIANT Occlusion Balloon Catheter 7mm x 15mm
- Model Identifier(s)
- M003ERC03100 M003ERC03150 M003ERC04100 M003ERC04150 M003ERC04200 M003ERC04300 M003ERC05100 M003ERC05150 M003ERC05200 M003ERC05300 M003ESC03050 M003ESC04070 M003ESC04100 M003ESC07070 M003ESC07100 M003ESC07150
About this record
Access comprehensive regulatory information for Stryker Neurovascular TransForm® Occlusion Balloon 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 DE0016743 and owned by Stryker Neurovascular. The device was registered on January 16, 2015.
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