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Singapore HSA registration DE0019286

Gambro Water Treatment System CWP 800

Singapore flagSingapore·CLASS C·Gambro Lundia AB·Registered May 31, 2017
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0019286
Registration Date
May 31, 2017
Change Notification Approval Date
April 18, 2024
Retention Due Date
May 30, 2025
Product description
The CWP system (Central Water Plant) is designed to be used as a dialysis accessory device to obtain purified water by using the reverse osmosis concept. The CWP system can be used in conjunction with dialysis machines provided that the input flow and pressure demands correspond to the output of the CWP system and that they comply with IEC 60601-2-16. The device is designed for hospital or clinic use.
Product Owner
Name
Gambro Lundia AB
Short Name
Gambro Lundia AB
Address
Box 10101, Magistratsvägen 16, SE-220 10 Lund, SWEDEN
Registrant
Name
VANTIVE PTE. LTD.
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
Name
BAXTER HEALTHCARE (ASIA) PTE LTD VANTIVE PTE. LTD.
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)
CWP 800 RO1 CWP 800 RO2 CWP 800 EXT1 CWP 800 EXT2 CWP 800 HW
Model Identifier(s)
115641 115642 115643 115644 115645
About this record

Access comprehensive regulatory information for Gambro Water Treatment System CWP 800 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019286 and owned by Gambro Lundia AB. The device was registered on May 31, 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.

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