Singapore HSA registration DE0505770
Gambro Prismaflex HP-X Set
Singapore·CLASS B·Gambro Industries·Registered May 11, 2021Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B