Pure Global
Singapore HSA registration DE0509065

Cardioline Cubestress System

Singapore flagSingapore·CLASS B·Cardioline S.p.a.·Registered March 15, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509065
Registration Date
March 15, 2024
Retention Due Date
March 14, 2026
Product description
Cubestress System is intended for the performance of cardiovascular stress tests. It aims to analyse ECG signals, acquired and transmitted wirelessly with the HD + / CLICKECG-HD, HD+12, CLICKECG-HD 12, HD+15, CLICKECG-HD 15 units, and other biometric data (non-invasive blood pressure, SpO2), acquired with the unit mounted on an ergometer, during the performance of cardiovascular stress tests for the assessment and diagnosis of cardiac functions. Stress may be induced with the use of the software-controller ergometer.
Product Owner
Name
Cardioline S.p.a.
Short Name
Cardioline S.p.a.
Address
Via Linz, 151, IT-38121 Trento (TN), ITALY
Registrant
Name
SCANMED TECHNOLOGY (S) PTE LTD
Address
192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381
Importer
Name
SCANMED TECHNOLOGY (S) PTE LTD
Address
192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381
Model information
Model Name(s)
Cubestress System config. Package HD+ 15 Cubestress System config. Laser printer B/N and ISO HD+ 15 Cubestress System config. Thermal printer 200P and ISO HD+ 15 Cubestress System config. Laser printer B/N HD+ 15 Cubestress System config. Thermal printer 200P HD+ 15 Cubestress System config. Package HD+ 12 Cubestress System config. Laser printer B/N and ISO HD+ 12 Cubestress System config. Thermal printer 200P and ISO HD+ 12 Cubestress System config. Laser printer B/N HD+ 12 Cubestress System config. Thermal printer 200P HD+ 12 Cubestress System config. Package HD+ Cubestress System config. Laser printer B/N and ISO HD+ Cubestress System config. Thermal printer 200P and ISO HD+ Cubestress System config. Laser printer B/N HD+ Cubestress System config. Thermal printer 200P HD+
Model Identifier(s)
KSSE00000 KSSEPCTL0 KSSEPCTT0 KSSEPCUL0 KSSEPCUT0 KSSM00000 KSSMPCTL0 KSSMPCTT0 KSSMPCUL0 KSSMPCUT0 KSSN00000 KSSNPCTL0 KSSNPCTT0 KSSNPCUL0 KSSNPCUT0
About this record

Access comprehensive regulatory information for Cardioline Cubestress System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509065 and owned by Cardioline S.p.a.. The device was registered on March 15, 2024.

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