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Singapore HSA registration DE0501548

Gambro Artiset PrePost

Singapore flagSingapore·CLASS B·Gambro Dasco S.p.A·Registered April 20, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0501548
Registration Date
April 20, 2018
Change Notification Approval Date
April 18, 2024
Retention Due Date
April 19, 2026
Product description
The ArtiSet PREPOST is a single use sterile medical device (blood tubing system) intended to be used as an extracorporeal blood circuit for double needle Hemodialysis, Hemodiafiltration and Hemofiltration treatments on Artis/Evosys system. It can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. If connected to the proper accessories, it can be used to perform Hemodiafiltration and Hemofiltration treatments in pre or post dilution configuration, together with priming, bolus, rinseback, with substitution and infusion fluid on-line produced by the dialysis machine and filtered by a single use membrane designed for retention of bacteria and endotoxins.
Product Owner
Name
Gambro Dasco S.p.A
Short Name
Gambro Dasco S.p.A
Address
Medolla Facility, Via Modenese 66, Medolla (MO), 41036 Italy, ITALY
Registrant
Name
VANTIVE PTE. LTD.
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
Name
BAXTER HEALTHCARE (ASIA) PTE LTD VANTIVE PTE. LTD.
Address
150 BEACH ROAD, GATEWAY WEST, #30-01/08, SINGAPORE 189720 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model information
Model Name(s)
Artiset Prepost
Model Identifier(s)
955077
About this record

Access comprehensive regulatory information for Gambro Artiset PrePost in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501548 and owned by Gambro Dasco S.p.A. The device was registered on April 20, 2018.

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