Pure Global
Singapore HSA registration DE0507946

SIS MEDICAL OPN NC SUPER HIGH PRESSURE PTCA BALLOON CATHETER

Singapore flagSingapore·CLASS D·SIS Medical AG·Registered March 27, 2023
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0507946
Registration Date
March 27, 2023
Change Notification Approval Date
October 08, 2024
Retention Due Date
March 26, 2026
Product description
The PTCA Catheter is intended for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable coronary stents.
Product Owner
Name
SIS Medical AG
Short Name
SIS Medical AG
Address
Hungerbuelstrasse 12a, CH-8500 Frauenfeld, 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)
OPN NC 1.5 x 10 mm OPN NC 1.5 x 15 mm OPN NC 1.5 x 20 mm OPN NC 2.0 x 10 mm OPN NC 2.0 x 15 mm OPN NC 2.0 x 20 mm OPN NC 2.5 x 10 mm OPN NC 2.5 x 15 mm OPN NC 2.5 x 20 mm OPN NC 3.0 x 10 mm OPN NC 3.0 x 15 mm OPN NC 3.0 x 20 mm OPN NC 3.5 x 10 mm OPN NC 3.5 x 15 mm OPN NC 3.5 x 20 mm OPN NC 4.0 x 10 mm OPN NC 4.0 x 15 mm OPN NC 4.0 x 20 mm OPN NC 4.5 x 10 mm OPN NC 4.5 x 15 mm OPN NC 4.5 x 20 mm
Model Identifier(s)
150-010-004 150-015-004 150-020-004 200-010-004 200-015-004 200-020-004 250-010-004 250-015-004 250-020-004 300-010-004 300-015-004 300-020-004 350-010-004 350-015-004 350-020-004 400-010-004 400-015-004 400-020-004 450-010-004 450-015-004 450-020-004
About this record

Access comprehensive regulatory information for SIS MEDICAL OPN NC SUPER HIGH PRESSURE 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 DE0507946 and owned by SIS Medical AG. The device was registered on March 27, 2023.

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 D