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Quara S.r.l.

ItalyFDA applicant, unverified

Devices
1

What Quara S.r.l. makes

Quara S.R.L. manufactures heat exchangers, including the Quantum PureFlow Standard series (models HX11W-S2, HX11W-S1M, and HX11W-S2M), designed for thermal transfer applications in medical and industrial settings.

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

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

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Frequently asked questions

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

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

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

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

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

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

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

The most recently registered devices listed for Quara S.R.L. include Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M).

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