Singapore HSA registration DE0019159
Gambro ArtiSet HD DNL HC Blood Tubing Set
Singapore·CLASS B·Gambro Dasco S.p.A.·Registered April 13, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0019159
- Registration Date
- April 13, 2017
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- April 12, 2026
Product description
ArtiSet HD DNL HC is a single use sterile medical device (blood tubing system) intended to be used as an extracorporeal blood circuit for double needle hemodialysis treatment on Artis system. It can be safely connected to dialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. ArtiSet HD DNL HC, when used on Artis Physio and connected to the proper accessories listed into Artis Operator’s Manual, can be used to perform Hemodiafiltration (HDF) in postdilution 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. In addition, ArtiSet HD DNL HC, when connected to the dedicated accessory described in the Artis Operator‘s Manuals, can be used to perform AFB K treatments.
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)
- Artiset HD DNL HC Artiset HD DNL HC
- Model Identifier(s)
- 955075 955549
About this record
Access comprehensive regulatory information for Gambro ArtiSet HD DNL HC Blood Tubing Set in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019159 and owned by Gambro Dasco S.p.A.. The device was registered on April 13, 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