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Singapore HSA registration DE0508498

Cardioline® TouchECG System

Singapore flagSingapore·CLASS B·Cardioline S.p.a.·Registered September 20, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508498
Registration Date
September 20, 2023
Retention Due Date
September 19, 2025
Product description
TouchECG System is intended for the acquisition of resting ECG exams to check and diagnose cardiac functions. However, a physician must validate the results of the analysis performed by the ECG device. It is intended for analysing ECG signals, acquired and transmitted with the HD+ acquisition device (HD + / CLICKECG‐HD, HD+ 12 / CLICKECG‐HD 12, HD+ 15 / CLICKECG‐HD 15). TouchECG System is intended for use in hospitals, clinics and outpatient departments of any size. It is suitable for use by health workers. The analysis of ECG traces and the automatic interpretation must always be validated by a physician. The device can't diagnose the patient condition by itself, but only display the results of the ECG interpretation according to Glasgow Resting ECG Analysis program.
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)
Acquisition unit Acquisition unit Acquisition unit ECGWebApp TouchECG TouchECG TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) TouchECG System (Windows) touchECG System - DIGITAL PREMIUM configuration touchECG System - DIGITAL configuration TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android) TouchECG System (Android)
Model Identifier(s)
81018027 81018028 81018127 81019560 81019579 81019582 KTCH30000 KTCH30000-A KTCH30000-AE KTCH30000-E KTCH30000-MG KTCH30000-SL KTCH30000-SLD KTCH3000E KTCH3000E-A KTCH3000E-AE KTCH3000E-E KTCH3000E-MG KTCH3000E-SL KTCH3000E-SLD KTCH3000N KTCH3000N-A KTCH3000N-AE KTCH3000N-E KTCH3000N-MG KTCH3000N-SL KTCH3000N-SLD KTCH3PBT0 KTCH3PBT0-A KTCH3PBT0-AE KTCH3PBT0-E KTCH3PBT0-SL KTCH3PBTE KTCH3PBTE-A KTCH3PBTE-AE KTCH3PBTE-E KTCH3PBTE-SL KTCH3PBTN KTCH3PBTN-A KTCH3PBTN-AE KTCH3PBTN-E KTCH3PBTN-SL KTCH3PCS0 KTCH3PCS0-A KTCH3PCSE KTCH3PCSE-A KTCH3PCSE-SL KTCH3PCSN KTCH3PCSN-A KTCH3PCSN-SL KTCH3PCT0 KTCH3PCT0-A KTCH3PCT0-AE KTCH3PCT0-E KTCH3PCTE KTCH3PCTE-A KTCH3PCTE-AE KTCH3PCTE-E KTCH3PCTN KTCH3PCTN-A KTCH3PCTN-AE KTCH3PCTN-E KTCH3XXYZ -@ KTCH3XXYZ-@ KTCHA0000 KTCHA0000-A KTCHA0000-AE KTCHA0000-E KTCHA0000-SL KTCHA0001-G KTCHA0002 KTCHA0002-G KTCHATA00 KTCHATA0R
About this record

Access comprehensive regulatory information for Cardioline® TouchECG 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 DE0508498 and owned by Cardioline S.p.a.. The device was registered on September 20, 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.

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