Welch Allyn H12+ 12-Lead Holter - HSA Registration DE0506340
Access comprehensive regulatory information for Welch Allyn H12+ 12-Lead Holter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506340 and owned by Welch Allyn, Inc.. The device was registered on November 03, 2021.
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 H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the H12+ recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the HScribe Holter system. The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 48 hours. The H12+ does not perform cardiac analysis by itself and is intended to be used with the HScribe™ Holter analysis system. ECG data pre-recorded by the H12+ is acquired and analyzed by the HScribe Holter analysis system.