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Eko.Ai Pte Ltd. D/B/A US2.Ai

SingaporeFDA applicant, unverified

Devices
3

What Eko.Ai Pte Ltd. D/B/A US2.Ai makes

Eko.Ai Pte Ltd. produces software-based medical devices including Us2.ca, Us2.v2, and Us2.v1. These products function as automated analysis tools for echocardiography.

The company is based in the US, and its portfolio consists of Class II medical devices. These devices are listed in the FDA 510(k) regulatory registry.

AI-generated from registry data, 28 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Us2.ca Ref K250151

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

  • Us2.v2 Ref K233676

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

  • Us2.v1 Ref K210791

    Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II

Frequently asked questions

How many devices does Eko.Ai Pte Ltd. D/B/A Us2.Ai have in the registry?

The registry currently lists 3 devices for Eko.Ai Pte Ltd. D/B/A Us2.Ai. Devices recorded under merged duplicate company entries are counted once.

Which registries list Eko.Ai Pte Ltd. D/B/A Us2.Ai's devices?

Among its 3 most recently registered devices, Eko.Ai Pte Ltd. D/B/A Us2.Ai has devices listed in EUDAMED (1 device), FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Eko.Ai Pte Ltd. D/B/A Us2.Ai's devices fall under?

Among its 3 most recently registered devices, the classes recorded for Eko.Ai Pte Ltd. D/B/A Us2.Ai's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Eko.Ai Pte Ltd. D/B/A Us2.Ai in the registry?

The most recently registered devices listed for Eko.Ai Pte Ltd. D/B/A Us2.Ai include Us2.ca, Us2.v2 and Us2.v1.

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