Datrix LLC
United StatesFDA applicant, unverified FDA FEI 1000125122
Datrix LLC is a medical device manufacturer, with 40 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 40
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 35
- FDA 510(k) 5
- Device classes
- FDA Class II 40
- Identifiers
- FDA FEI 1000125122
- DUNS 080555401
At a glance
Market reach
- United States
- FDA FEI
What Datrix LLC makes
Datrix LLC manufactures ambulatory electrocardiographic (ECG) monitoring devices, including telemetric and non-telemetric recorders designed for continuous cardiac rhythm assessment. Their portfolio includes systems for both professional and patient-worn monitoring, such as long-term Holter-like recorders and event monitors for detecting arrhythmias.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Datrix LLC operates from the United States.
Catalogue
Search and filter all 40 devicesCompany details
- FDA FEI number
- 1000125122
- DUNS number
- 080555401
- Address
- 382 State Pl, Escondido, CA, 92029
- udi@intricon.com
- Phone
- 651-636-9770
Frequently asked questions
How many devices does DATRIX LLC have in the registry?
The registry currently lists 40 devices for DATRIX LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list DATRIX LLC's devices?
Among its 40 most recently registered devices, DATRIX LLC has devices listed in FDA 510(k) (5 devices) and FDA GUDID (35 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do DATRIX LLC's devices fall under?
Among its 40 most recently registered devices, the classes recorded for DATRIX LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from DATRIX LLC in the registry?
The most recently registered devices listed for DATRIX LLC include HeartcoR Sentinel, VX3+ VX3+ Series M, Datrix VX3+ Series T and AMI RX93030-001.