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Pediametrix, Inc.

Country not established

Devices
2

What Pediametrix, Inc. makes

Pediametrix, Inc. manufactures the SoftSpot, a device designed for measuring and monitoring pediatric head circumference, commonly used in neonatal and infant care settings to assess growth and developmental milestones.

The SoftSpot is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • SoftSpot

    None Registry: GUDID Class:I
  • SoftSpot Ref K212045

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

Company details

DUNS number
081060963
Phone
2406700171

Frequently asked questions

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

The registry currently lists 2 devices for Pediametrix, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pediametrix, Inc.'s devices?

Among its 2 most recently registered devices, Pediametrix, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

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

Among its 2 most recently registered devices, the classes recorded for Pediametrix, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Pediametrix, Inc. include SoftSpot.

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