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Gambro Ultra Prime Line - HSA Registration DE0501127

Access comprehensive regulatory information for Gambro Ultra Prime 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 DE0501127 and owned by Gambro Dasco S.p.A.. The device was registered on January 23, 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.

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CLASS B
DE0501127
Gambro Ultra Prime Line
HSA Registration Number: DE0501127
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Product Description

The Ultra Prime Line is a single use sterile medical device intended to be connected to proper ArtiSet blood tubing system used on Artis/Evosys Physio dialysis machines. The accessory Ultra Prime Line allows to perform priming, bolus and rinseback in Hemodialysis treatments with infusion fluid on-line produced by the dialysis machine and filtered by a single use sterilizing membrane.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501127
Registration Date
January 23, 2018
Change Notification Approval Date
April 18, 2024
Retention Due Date
January 22, 2026
Product Owner
Short Name
Gambro Dasco S.p.A
Address
Via Modenese 66, 41036 Medolla (MO), ITALY
Registrant
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
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 Prime Line Gambro Ultra Prime Line
Model Identifier(s)
115282 955490