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Trinity Guardion

Also registered as Trinity Guardion, Inc.

Country not established

Trinity Guardion is a medical device manufacturer, with 55 devices listed in FDA GUDID and FDA 510(k) (FDA Class I) as of 13 Nov 2026.

Devices
55

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 54
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class I 55

What Trinity Guardion makes

Trinity Guardion manufactures reusable, waterproof mattress and bed covers designed to protect hospital and healthcare facility mattresses from liquid and soil contamination. The products include standard and pediatric-specific barriers, all intended for single-patient use before disposal.

The company’s portfolio is classified under FDA Class I medical devices and is listed in the FDA’s 510(k) and UDI registries.

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

Catalogue55

Newest first, rows 1-50 of 55

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Frequently asked questions

How many devices does Trinity Guardion have in the registry?

The registry currently lists 55 devices for Trinity Guardion. Devices recorded under merged duplicate company entries are counted once.

Which registries list Trinity Guardion's devices?

Among its 50 most recently registered devices, Trinity Guardion has devices listed in FDA GUDID (50 devices).

What risk classes do Trinity Guardion's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Trinity Guardion's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Trinity Guardion in the registry?

The most recently registered devices listed for Trinity Guardion include Soteria Bed Barrier Linet Ave2 Head LINAVE-000H, Soteria Bed Barrier Linet Ave2 Foot LINAVE-000F, Soteria Neonatal Mattress Barrier Atom Bassinet ATMBAS-0000 and Soteria Mattress Barrier Universal 84x35x8 843508-0E00.

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