Singapore HSA registration DE0503959
Cordis RAILWAY™ Sheathless Access System
Singapore·CLASS B·Cordis US Corp.·Registered December 19, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0503959
- Registration Date
- December 19, 2019
- Change Notification Approval Date
- March 19, 2024
- Retention Due Date
- December 18, 2025
Product description
The RAILWAY™ Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.
Product Owner
- Name
- Cordis US Corp.
- Short Name
- Cordis US Corp.
- Address
- 14201 North West 60th Avenue, Miami Lakes, Florida 33014, Florida, UNITED STATES
Registrant
- Address
- 600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #05-01, SINGAPORE 188778
Importer
- Address
- 10 KALLANG AVENUE, APERIA, #10-10/18, SINGAPORE 339510 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model information
- Model Name(s)
- RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System RAILWAY™ Sheathless Access System
- Model Identifier(s)
- RW5ADTB RW5ADTH RW5VBTB RW5VBTH RW6ADTB RW6ADTH RW6VBTB RW6VBTH RW7VBTB RW7VBTH
About this record
Access comprehensive regulatory information for Cordis RAILWAY™ Sheathless Access System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503959 and owned by Cordis US Corp.. The device was registered on December 19, 2019.
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 B