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Baxter Connection Shield System II with Povidone-Iodine Solution - HSA Registration DE0502039

Access comprehensive regulatory information for Baxter Connection Shield System II with Povidone-Iodine Solution in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502039 and owned by Baxter Healthcare SA. The device was registered on August 17, 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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CLASS B
DE0502039
Baxter Connection Shield System II with Povidone-Iodine Solution
HSA Registration Number: DE0502039
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Product Description

The Baxter Connection Shield System II with Povidone-Iodine Solution is a plastic hinged shell for peritoneal dialysis and contains a sponge soaked in povidone-iodine solution intended to protect the Luer connection between a Baxter transfer set and a Continuous Ambulatory Peritoneal Dialysis (CAPD) solution set or an Automated Peritoneal Dialysis (APD) disposable set.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502039
Registration Date
August 17, 2018
Change Notification Approval Date
April 18, 2024
Retention Due Date
August 16, 2025
Product Owner
Short Name
Baxter Healthcare SA
Address
P.O. Box, 8010 Zurich, SWITZERLAND
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)
Connection Shield SysII with Povidone-Iodine Solution
Model Identifier(s)
SPC4211