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Singapore HSA registration DE0500911

Gambro Ultra HDF Line

Singapore flagSingapore·CLASS B·Gambro Dasco S.p.A.·Registered November 24, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0500911
Registration Date
November 24, 2017
Change Notification Approval Date
April 18, 2024
Retention Due Date
November 23, 2025
Product description
The accessory Ultra HDF Line is a single use sterile medical device intended to be connected to proper ArtiSet blood tubing system used on Artis Physio and Evosys Physio dialysis machines to allow Hemodiafiltration (HDF) and Hemofiltration (HF) treatments in pre or postdilution configuration, together with on-line priming, bolus and rinseback, with substitution and infusion fluid on-line produced by the dialysis machine and filtered by a single use hollow fiber ultrafilter designed for retention of bacteria and endotoxins.
Product Owner
Name
Gambro Dasco S.p.A.
Short Name
Gambro Dasco S.p.A.
Address
Via Modenese 66, 41036, Medolla (MO), 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)
Gambro Ultra HDF Line
Model Identifier(s)
115283
About this record

Access comprehensive regulatory information for Gambro Ultra HDF Line in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500911 and owned by Gambro Dasco S.p.A.. The device was registered on November 24, 2017.

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