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Gallini S.r.l.

Country not established

Devices
1

What Gallini S.r.l. makes

Gallini S.R.L. manufactures biopsy needles designed for tissue sampling procedures, specifically for transrectal (TX) applications in medical diagnostics.

The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the U.S. regulatory database. The manufacturer 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

  • Tx Biopsy Needle Ref K962905

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

Frequently asked questions

How many devices does Gallini S.R.L. have in the registry?

The registry currently lists 1 device for Gallini S.R.L.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gallini S.R.L.'s devices?

Among its 1 most recently registered device, Gallini S.R.L. has devices listed in FDA 510(k) (1 device).

What risk classes do Gallini S.R.L.'s devices fall under?

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

What are the newest devices from Gallini S.R.L. in the registry?

The most recently registered devices listed for Gallini S.R.L. include TX BIOPSY NEEDLE.

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