Pure Global

Cordis RAILWAY™ Sheathless Access System - HSA Registration DE0503959

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0503959
Cordis RAILWAY™ Sheathless Access System
HSA Registration Number: DE0503959
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The RAILWAY™ Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.

Device 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 Owner
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