Pure Global
Singapore HSA registration DE0503301

Argon Cleaner Rotational Thrombectomy System

Singapore flagSingapore·CLASS D·Argon Medical Devices, Inc·Registered June 28, 2019
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0503301
Registration Date
June 28, 2019
Retention Due Date
June 27, 2025
Product description
The Cleaner Rotational Thrombectomy System is indicated for (1) mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts; and (2) mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics in the peripheral vasculature.
Product Owner
Name
Argon Medical Devices, Inc
Short Name
Argon Medical Devices, Inc
Address
1445 Flat Creek Road, Athens,, Texas 75751, UNITED STATES, UNITED STATES
Registrant
Name
ARGON MEDICAL ASIA PTE. LTD.
Address
8 KENSINGTON PARK DRIVE, KENSINGTON PARK, #01-01, SINGAPORE 557323
Importer
Name
SingMed Healthcare Systems
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model information
Model Name(s)
CleanerXTTM Rotational Thrombectomy System Cleaner15TM Rotational Thrombectomy System CleanerXTTM Rotational Thrombectomy System Cleaner15TM Rotational Thrombectomy System
Model Identifier(s)
700009XT 700015 700109XT 700115
About this record

Access comprehensive regulatory information for Argon Cleaner Rotational Thrombectomy System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503301 and owned by Argon Medical Devices, Inc. The device was registered on June 28, 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 D