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Gambro Prismaflex HP-X Set - HSA Registration DE0505770

Access comprehensive regulatory information for Gambro Prismaflex HP-X Set in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505770 and owned by Gambro Industries. The device was registered on May 11, 2021.

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
DE0505770
Gambro Prismaflex HP-X Set
HSA Registration Number: DE0505770
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Product Description

The Prismaflex HP-X set is a set of blood lines intended for extracorporeal circulation of blood on the control unit and designed to be connected to blood purification devices.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0505770
Registration Date
May 11, 2021
Change Notification Approval Date
April 18, 2024
Retention Due Date
May 10, 2026
Product Owner
Short Name
Gambro Industries
Address
7, Avenue Lionel Terray, BP126, 69883 Meyzieu Cedex, FRANCE
Registrant
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model Information
Model Name(s)
Prismaflex HP-X Set
Model Identifier(s)
114877