Singapore HSA registration DE0019336
Gambro ARTIS 230V Physio II
Singapore·CLASS C·Gambro Dasco S.p.A·Registered June 15, 2017Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0019336
- Registration Date
- June 15, 2017
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- June 14, 2025
Product description
The Artis Dialysis System is intended to perform intermittent Hemodialysis (HD), Hemofiltration (HF) and Hemodiafiltration (HDF) therapies. The Artis Dialysis System is intended to treat patients with chronic or acute renal failure upon prescription by a physician.
Product Owner
- Short Name
- Gambro Dasco S.p.A
- Address
- Medolla Facility, Via Modenese 66, Medolla (MO), 41036 Italy, 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)
- ARTIS 230V Physio II
- Model Identifier(s)
- 955412
About this record
Access comprehensive regulatory information for Gambro ARTIS 230V Physio II in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019336 and owned by Gambro Dasco S.p.A. The device was registered on June 15, 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 C