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Baxter Sharesource Adequest - HSA Registration DE0508129

Access comprehensive regulatory information for Baxter Sharesource Adequest in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508129 and owned by Baxter Healthcare SA. The device was registered on May 25, 2023.

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
DE0508129
Baxter Sharesource Adequest
HSA Registration Number: DE0508129
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Product Description

Sharesource Adequest is a stand-alone software application used by healthcare professionals to calculate solute clearances and net fluid removal for individual patients undergoing peritoneal dialysis based on therapy parameters provided by the clinician, thus eliminating the need for the clinician to perform manual calculations. These equations are obtained from published literature based on the patientโ€™s age, gender, and body habitus. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508129
Registration Date
May 25, 2023
Change Notification Approval Date
April 23, 2025
Retention Due Date
May 24, 2025
Product Owner
Short Name
Baxter Healthcare SA
Address
Thurgauerstrasse 130, 8152 Glattpark (Opfikon), SWITZERLAND
Registrant
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model Information
Model Name(s)
Sharesource Adequest
Model Identifier(s)
5CGM20