Ultromics, Ltd.
United KingdomFDA applicant, unverified FDA FEI 3016585383
Ultromics, Ltd. is a medical device manufacturer, with 13 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 13
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 7
- FDA 510(k) 6
- Device classes
- FDA Class II 12
- FDA Class I 1
- Identifiers
- FDA FEI 3016585383
At a glance
Market reach
- United States
- FDA FEI
What Ultromics, Ltd. makes
Ultromics, Ltd. develops application software for cardiac mapping, ultrasound imaging, and radiology DICOM processing. Their products include versions of EchoGo, designed for cardiac ultrasound analysis, and EchoGo Core and Pro, tailored for specific diagnostic workflows in echocardiography.
The company’s software portfolio is classified as Class II under FDA regulations and is listed via 510(k) and UDI submissions. These devices are authorised for use in the United States, where Ultromics, Ltd. is based.
Catalogue
Search and filter all 13 devicesCompany details
- FDA FEI number
- 3016585383
- Address
- 4630 Kingsgate, Cascade Way, Oxford Oxfordshire
Frequently asked questions
How many devices does Ultromics, Ltd. have in the registry?
The registry currently lists 13 devices for Ultromics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ultromics, Ltd.'s devices?
Among its 13 most recently registered devices, Ultromics, Ltd. has devices listed in FDA 510(k) (6 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ultromics, Ltd.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Ultromics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ultromics, Ltd. in the registry?
The most recently registered devices listed for Ultromics, Ltd. include EchoGo Workstream 1.0, EchoGo Core, EchoGo Heart Failure 2.0 and EchoGo Core 2.0.