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Gambro Re-infusion Line - HSA Registration DE0506761

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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CLASS B
DE0506761
Gambro Re-infusion Line
HSA Registration Number: DE0506761
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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.

Device 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 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