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Darcy, Inc.

Country not established

Devices
1

What Darcy, Inc. makes

Darcy, Inc. manufactures the Cuddle Cap, a non-invasive infant sleep aid designed to reduce nighttime wake-ups by maintaining optimal temperature and humidity for infants.

The Cuddle Cap is classified under the FDA’s 510(k) pathway and is listed in the U.S. regulatory database. The company 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

  • Cuddle Cap Ref K812216

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

Frequently asked questions

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

The registry currently lists 1 device for Darcy, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Darcy, Inc.'s devices?

Among its 1 most recently registered device, Darcy, Inc. has devices listed in FDA 510(k) (1 device).

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

The most recently registered devices listed for Darcy, Inc. include CUDDLE CAP.

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