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Singapore HSA registration DE0002116

Gambro WRO 300 Water Purification Unit

Singapore flagSingapore·CLASS C·Gambro Lundia AB·Registered November 17, 2005
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0002116
Registration Date
November 17, 2005
Change Notification Approval Date
April 25, 2025
Retention Due Date
August 09, 2025
Product description
The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. It is intended for use in conjuction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 unit.
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)
WRO 300H WRO 300H WRO 300
Model Identifier(s)
114780 955686 W100001001
About this record

Access comprehensive regulatory information for Gambro WRO 300 Water Purification Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0002116 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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