Datrix LLC

Datrix LLC is a commercial ambulatory ECG device manufacturer established in 1988 and incorporated as an LLC in 2017. The company designs, manufactures, and distributes Holter monitors and ambulatory cardiac monitoring devices to dealers and medical equipment companies globally. Primary products include the VX3 Holter Recorder, a traditional 3-channel device available in 5 or 7-wire configurations, and the Sirona, a versatile 4-in-1 ambulatory monitor supporting event, post-event, and Holter monitoring modes with configurable lead options or patch-based monitoring. Datrix maintains ISO 13485 certification and FDA registration for its manufacturing facility, ensuring compliance with FDA Quality Systems Regulations. The company leverages strategic relationships with ISO 13485-registered contract manufacturers in Asia to support its production capabilities. Quality systems emphasize design and process validation, equipment qualification, lot traceability, and compliance testing, with continuous improvement through Lean Manufacturing practices. Datrix serves the ambulatory cardiac monitoring segment, supporting clinical requirements for long-term heart rhythm monitoring in diverse care settings.