Singapore HSA registration DE0008696
Gambro ARTIS haemodialysis system
Singapore·CLASS C·Gambro Dasco S.p.A.·Registered February 27, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0008696
- Registration Date
- February 27, 2012
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- February 26, 2026
Product description
Intended for use as a single patient machine to perform High and Low Flux Hemodialysis (HD) and Hemodiafiltration (HDF) therapies. The Artis Dialysis System is intended to be used with high and low permeability dialyzers.
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)
- ARTIS Hemodialysis Monitor - 230 V ArtiSet ULTRA HC ArtiSet HD SN HC SNSP Expansion Chamber Holder Sampling Kit GMB-SP 402 CHILD CUFF(12-19CM) L.F. SMALL AD.CUFF(17-25CM)LF ADULT CUFF (23-33CM) L.F LARGE AD.CUFF (31-40CM) L.F THIGH CUFF (38-50CM) L.F BPM Tube
- Model Identifier(s)
- 110635 112559 113591 113678 6032650 6993513 6993521 6993539 6993547 6993554 6993588
About this record
Access comprehensive regulatory information for Gambro ARTIS haemodialysis system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008696 and owned by Gambro Dasco S.p.A.. The device was registered on February 27, 2012.
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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