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Singapore HSA registration DE0508667

Cardioline S.P.A ECG100S

Singapore flagSingapore·CLASS B·Cardioline S.p.a.·Registered November 17, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0508667
Registration Date
November 17, 2023
Retention Due Date
November 16, 2025
Product description
The Device is a high-performance, multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via Internet or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer. The device is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.
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)
ECG 100S
Model Identifier(s)
80508096S
About this record

Access comprehensive regulatory information for Cardioline S.P.A ECG100S in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508667 and owned by Cardioline S.p.a.. The device was registered on November 17, 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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