Welch Allyn® ELI 280® Resting Electrocardiograph - HSA Registration DE0504056
Access comprehensive regulatory information for Welch Allyn® ELI 280® Resting Electrocardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504056 and owned by Welch Allyn, Inc.. The device was registered on January 22, 2020.
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.
The ELI 280 Electrocardiograph is a 12-lead diagnostic electrocardiograph capable of acquiring, viewing, transmitting, printing, and storing 12-lead ECG data. • Device is indicated for use to provide interpretation of the data for consideration by a physician. • Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. • Device is indicated for use on adult and pediatric populations. • The device is not intended to be used as a vital signs physiological monitor.