Singapore HSA registration DE0503913

Biosensors RISE™ NC Non-Compliant PTCA Balloon Catheter

Singapore·CLASS D·Biosensors Europe SA·Registered December 09, 2019

Device classification

Device Class: CLASS D
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0503913
Registration Date: December 09, 2019
Change Notification Approval Date: December 13, 2024
Retention Due Date: December 08, 2025

Product description

The Biosensors RISE NC PTCA Balloon Catheter is indicated for: 1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) post-delivery expansion of balloon expandable coronary stents.

Product Owner

Name: Biosensors Europe SA
Short Name: Biosensors
Address: Rue de Lausanne 29, 1110 Morges, SWITZERLAND

Registrant

Name: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.
Address: 36 JALAN TUKANG, SINGAPORE 619266

Importer

Name: BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.
Address: 36 JALAN TUKANG, SINGAPORE 619266

Model information

Model Name(s): RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC RISE NC
Model Identifier(s): NCB-20008 NCB-20010 NCB-20012 NCB-20015 NCB-20020 NCB-20025 NCB-22508 NCB-22510 NCB-22512 NCB-22515 NCB-22520 NCB-22525 NCB-25008 NCB-25010 NCB-25012 NCB-25015 NCB-25020 NCB-25025 NCB-27508 NCB-27510 NCB-27512 NCB-27515 NCB-27520 NCB-27525 NCB-30008 NCB-30010 NCB-30012 NCB-30015 NCB-30020 NCB-30025 NCB-32508 NCB-32510 NCB-32512 NCB-32515 NCB-32520 NCB-32525 NCB-35008 NCB-35010 NCB-35012 NCB-35015 NCB-35020 NCB-35025 NCB-37508 NCB-37510 NCB-37512 NCB-37515 NCB-37520 NCB-37525 NCB-40008 NCB-40010 NCB-40012 NCB-40015 NCB-40020 NCB-40025 NCB-45008 NCB-45010 NCB-45012

About this record

Access comprehensive regulatory information for Biosensors RISE™ NC Non-Compliant PTCA Balloon Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503913 and owned by Biosensors Europe SA. The device was registered on December 09, 2019.

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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