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Gambro Prismaflex TPE1000 Set - HSA Registration DE0006406

Access comprehensive regulatory information for Gambro Prismaflex TPE1000 Set in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006406 and owned by Gambro Industries. The device was registered on March 25, 2011.

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 C
DE0006406
Gambro Prismaflex TPE1000 Set
HSA Registration Number: DE0006406
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Product Description

The PRISMAFLEX TPE1000/TPE2000 Set is indicated for use only with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy (therapeutic plasma exchange). The PRISMAFLEX TPE1000/TPE2000 Set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0006406
Registration Date
March 25, 2011
Change Notification Approval Date
April 18, 2024
Retention Due Date
March 24, 2026
Product Owner
Short Name
Gambro Industries
Address
7, Avenue Lionel Terray, BP 126, 69883 Meyzieu Cedex, FRANCE
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)
Gambro Prismaflex TPE Disposable Set - TPE 1000
Model Identifier(s)
107143