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dms-service myPatch® ECG Recorder - HSA Registration DE0018062

Access comprehensive regulatory information for dms-service myPatch® ECG 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 DE0018062 and owned by dms-service LLC. The device was registered on April 26, 2016.

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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CLASS B
DE0018062
dms-service myPatch® ECG Recorder
HSA Registration Number: DE0018062
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Product Description

The myPatch® ECG Recorder is a small digital Holter recorder intended for use by professionals to acquire ECG data from a patient in a clinical, point of care or at a patient setting. The myPatch® ECG Recorder can record ECG up to 7 days on the torso of a patient through a myPatch®-compatible ECG electrode (length or recording time is based on the sample rate and channel selection) The patient’s ECG is recorded to the myPatch® ECG Recorder and then transferred via the myPatch® Micro USB cable to a Holter analysis system for review by a physician or other qualified personnel.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0018062
Registration Date
April 26, 2016
Change Notification Approval Date
June 28, 2021
Retention Due Date
April 25, 2026
Product Owner
Short Name
dms-service LLC
Address
11845 W. Olympic Blvd, Ste 880W, Los Angeles, CA 90064, UNITED STATES
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Address
40A CIRCULAR ROAD, #02-00, SINGAPORE 049396
Model Information
Model Name(s)
myPatch®sl Holter Recorder myPatch®sl Electrode myPatch® Software Interface Utility
Model Identifier(s)
3000sl mpE3sl mpSW