Singapore HSA registration DE0501121
Gambro Water Treatment System CWP 100
Singapore·CLASS C·Gambro Lundia AB·Registered January 22, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0501121
- Registration Date
- January 22, 2018
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- January 21, 2026
Product description
The CWP unit (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 unit can be used in conjunction with dialysis machines provided that the input flow and pressure demands correspond to the output of the CWP unit 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
- 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)
- CWP 100, WRO 102H CWP 100, WRO 101H CWP 100, WRO 103H CWP 100, WRO 104H CWP 100, WRO 106H CWP 100, WRO 106H DP PLC program
- Model Identifier(s)
- 114853 114854 114855 114856 114857 114858 RD1201V2
About this record
Access comprehensive regulatory information for Gambro Water Treatment System CWP 100 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501121 and owned by Gambro Lundia AB. The device was registered on January 22, 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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