Welch Allyn H3+ Digital Holter Recorder - HSA Registration DE0504091
Access comprehensive regulatory information for Welch Allyn H3+ Digital Holter Recorder in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504091 and owned by Welch Allyn Inc.. The device was registered on February 06, 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 H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. Holter analysis is appropriate for the indications: Evaluation of adult patients with symptoms suggesting arrhythmia; Evaluation of adult patients with pacemakers; Reporting of time domain heart rate variability; Evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery); Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients; Clinical and epidemiological research studies and Infant patient evaluation is limited to QRS detection only.