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Ote-Biomedica Elettronica S.p.A.

Country not established

Devices
2

What Ote-Biomedica Elettronica S.p.A. makes

Ote-Biomedica Elettronica S.P.A manufactures the SIM 4000I and SIM 4000C, which are medical devices designed for invasive monitoring of blood pressure and central venous pressure in clinical settings.

These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Sim 4000I Ref K873845

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sim 4000C Ref K874548

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

Frequently asked questions

How many devices does Ote-Biomedica Elettronica S.P.A have in the registry?

The registry currently lists 2 devices for Ote-Biomedica Elettronica S.P.A. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ote-Biomedica Elettronica S.P.A's devices?

Among its 2 most recently registered devices, Ote-Biomedica Elettronica S.P.A has devices listed in FDA 510(k) (2 devices).

What risk classes do Ote-Biomedica Elettronica S.P.A's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Ote-Biomedica Elettronica S.P.A's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ote-Biomedica Elettronica S.P.A in the registry?

The most recently registered devices listed for Ote-Biomedica Elettronica S.P.A include SIM 4000I and SIM 4000C.

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