Singapore HSA registration DE0501127
Gambro Ultra Prime Line
Singapore·CLASS B·Gambro Dasco S.p.A.·Registered January 23, 2018Device 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 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.
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
About this record
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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