Singapore HSA registration DE0018062
dms-service myPatch® ECG Recorder
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 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.
Product Owner
- Name
- dms-service LLC
- 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
About this record
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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