Singapore HSA registration DE0002105
Gambro PRISMATHERM II™ Blood Warmer/Extension Line
Singapore·CLASS B·Gambro Dasco S.p.A.·Registered November 09, 2005Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0002105
- Registration Date
- November 09, 2005
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- December 31, 2025
Product description
It is an accessory employed in conjunction with a heater to warm a fluid (blood, infusion fluid, dialysate fluid, etc) for special treatments, with the aim to replace heat lost to the atmosphere in an extra-corporeal circulation.
Product Owner
- Short Name
- Gambro Dasco S.p.A
- Address
- Via Modenese 66, 41036 Medolla (MO), ITALY
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)
- Acessory Extension Line Acessory Extension Line
- Model Identifier(s)
- SP-381 SP-420
About this record
Access comprehensive regulatory information for Gambro PRISMATHERM II™ Blood Warmer/Extension Line in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0002105 and owned by Gambro Dasco S.p.A.. The device was registered on November 09, 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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