Singapore HSA registration DE0506761
Gambro Re-infusion Line
Singapore·CLASS B·Gambro Dasco S.p.A.·Registered March 29, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0506761
- Registration Date
- March 29, 2022
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- March 28, 2026
Product description
The I201 (Re-infusion line) is a single use sterile accessory, with a gravity feed configuration, addressed to provide a connection between infusion solution containers (rigid container or bottle), the patient access and the arterial line of the extracorporeal circuit for hemodialysis treatments.
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)
- I201 Re-infusion Line
- Model Identifier(s)
- 6031090A
About this record
Access comprehensive regulatory information for Gambro Re-infusion 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 DE0506761 and owned by Gambro Dasco S.p.A.. The device was registered on March 29, 2022.
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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