Skip to content

Sonitus Medical?Shanghai?Co., ltd.

Country not established FDA

Part of Sonitus Medical (Shanghai) Co., Ltd.

Devices
1
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Sonitus Medical?Shanghai?Co., ltd. makes

Sonitus Medical produces tooth-worn bone-conduction hearing aids designed to transmit sound vibrations through the teeth to the inner ear, bypassing the outer and middle ear. The SoundBite device is intended for individuals seeking an alternative to traditional hearing solutions.

The company’s portfolio is classified under FDA Class II devices and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • SoundBite G3

    None Registry: GUDID Class:II

Company details

DUNS number
544488215

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Sonitus Medical (Shanghai) Co., Ltd. shanghai · CN FEI 3014990990

Frequently asked questions

How many devices does Sonitus Medical?Shanghai?Co., ltd. have in the registry?

The registry currently lists 1 device for Sonitus Medical?Shanghai?Co., ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sonitus Medical?Shanghai?Co., ltd.'s devices?

Among its 1 most recently registered device, Sonitus Medical?Shanghai?Co., ltd. has devices listed in FDA GUDID (1 device).

What risk classes do Sonitus Medical?Shanghai?Co., ltd.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Sonitus Medical?Shanghai?Co., ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Sonitus Medical?Shanghai?Co., ltd. in the registry?

The most recently registered devices listed for Sonitus Medical?Shanghai?Co., ltd. include SoundBite G3.

Which FDA establishments are linked to Sonitus Medical?Shanghai?Co., ltd.?

1 FDA establishment is linked to Sonitus Medical?Shanghai?Co., ltd. in the registry; they are listed on the company page.

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