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Mattel, Inc.

Country not established

Devices
1

What Mattel, Inc. makes

Mattel, Inc. manufactures COOL SHADES, a Class I medical device designed for pediatric use, likely intended for sun protection or vision correction in children.

The device is regulated under FDA 510(k) clearance as a Class I product 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

  • Cool Shades Ref K872218

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

Frequently asked questions

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

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

Which registries list Mattel, Inc.'s devices?

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

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

Among its 1 most recently registered device, the classes recorded for Mattel, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Mattel, Inc. include COOL SHADES.

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