Pure Global
Singapore HSA registration DE0504926

Clearstream HALO ONE™ Thin-Walled Guiding Sheath

Singapore flagSingapore·CLASS D·Clearstream Technologies Ltd.·Registered September 15, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0504926
Registration Date
September 15, 2020
Change Notification Approval Date
October 29, 2024
Retention Due Date
September 14, 2025
Product description
The Halo One™ Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One™ Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature or the coronary vasculature.
Product Owner
Name
Clearstream Technologies Ltd.
Short Name
Clearstream Technologies Ltd.
Address
Moyne Upper, Enniscorthy, CO. Wexford, IRELAND
Registrant
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Name
BARD SINGAPORE PTE LTD BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #33-07/08, SINGAPORE 079903 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
Model Name(s)
HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath HALO ONE™ Thin-Walled Guiding Sheath
Model Identifier(s)
HLO41018 HLO41018F HLO41018FH HLO41018H HLO41035 HLO41035F HLO41035FH HLO41035H HLO42535 HLO42535H HLO44535 HLO47035 HLO49035 HLO51018 HLO51018F HLO51018FH HLO51018H HLO51035 HLO51035F HLO51035FH HLO51035H HLO52535 HLO52535H HLO54535 HLO57035 HLO59035 HLO61035 HLO61035F HLO61035FH HLO61035H HLO62535 HLO62535H
About this record

Access comprehensive regulatory information for Clearstream HALO ONE™ Thin-Walled Guiding Sheath in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504926 and owned by Clearstream Technologies Ltd.. The device was registered on September 15, 2020.

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