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Universo S.A.

Country not established

Devices
1

What Universo S.A. makes

Universo S.A. manufactures the ERG-JET ELECTRODE, a device used for electrocardiographic (ECG) testing and monitoring to record electrical activity of the heart.

The ERG-JET ELECTRODE is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Erg-Jet Electrode Ref K830557

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does Universo S.A. have in the registry?

The registry currently lists 1 device for Universo S.A.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Universo S.A.'s devices?

Among its 1 most recently registered device, Universo S.A. has devices listed in FDA 510(k) (1 device).

What risk classes do Universo S.A.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Universo S.A.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Universo S.A. in the registry?

The most recently registered devices listed for Universo S.A. include ERG-JET ELECTRODE.

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