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Gambro Water Treatment System CWP 60 - HSA Registration DE0002117

Access comprehensive regulatory information for Gambro Water Treatment System CWP 60 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0002117 and owned by Gambro Lundia AB. The device was registered on November 17, 2005.

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 C
DE0002117
Gambro Water Treatment System CWP 60
HSA Registration Number: DE0002117
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Product Description

The Gambro Water Treatment System has been specially designed to meet the unique requirements of the dialysis clinic. When properly maintained it will produce water of high quality both from a chemical and microbiological standpoint, provided that the raw water complies with normal standards for drinking water and has been properly pretreated.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0002117
Registration Date
November 17, 2005
Change Notification Approval Date
April 18, 2024
Retention Due Date
August 09, 2025
Product Owner
Short Name
Gambro Lundia AB
Address
Box 10101, Magistratsvรคgen 16, SE-220 10 Lund, SWEDEN
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)
WRO 61-64/66
Model Identifier(s)
WRO 61-64/66