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Lumedx

United Statesfrom the FDA registration address FDA FEI 3008012314

Lumedx is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 13 Nov 2026.

Devices
4
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 2
  • FDA GUDID 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 4
Identifiers
  • FDA FEI 3008012314

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

Catalogue4

Newest first, rows 1-4 of 4

  • HealthView ECG Manager 1.2.5

    Listed Registry: GUDID Class:II

  • HealthView CardioPACS 6.5.1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cardiopacs Ref K120514

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Healthview Ecg Manager Ref K123466

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

FDA FEI number
3008012314
Address
305 Church at N Hills St, Raleigh, NC, 27609

Frequently asked questions

How many devices does Lumedx have in the registry?

The registry currently lists 4 devices for Lumedx. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lumedx's devices?

Among its 4 most recently registered devices, Lumedx has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Lumedx's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Lumedx's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Lumedx in the registry?

The most recently registered devices listed for Lumedx include HealthView ECG Manager 1.2.5, HealthView CardioPACS 6.5.1, CARDIOPACS and HEALTHVIEW ECG MANAGER.

Generated automatically from registry data and not verified by a human reviewer.