Singapore HSA registration DE0006406
Gambro Prismaflex TPE1000 Set
Singapore·CLASS C·Gambro Industries·Registered March 25, 2011Device 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 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.
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
About this record
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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