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Kyoto Diagnostics, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
11

What Kyoto Diagnostics, Inc. makes

Kyoto Diagnostics, Inc. manufactures urine analyzer systems, urine test reagent strips, and specific medical devices such as glucose analyzers and osmotic pressure analyzers.

The company's products are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Kyoto Diagnostics is based in the US.

AI-generated from registry data, 30 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Kyoto Diagnostics, Inc. have in the registry?

The registry currently lists 11 devices for Kyoto Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kyoto Diagnostics, Inc.'s devices?

Among its 11 most recently registered devices, Kyoto Diagnostics, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Kyoto Diagnostics, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Kyoto Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Kyoto Diagnostics, Inc. in the registry?

The most recently registered devices listed for Kyoto Diagnostics, Inc. include URINE ANALYZER SYSTEM, KYOTEST 5V, ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS and KYOTEST UGK.

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