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United Hayek Industries (Manufacturing) Limited

Country not established FDA

Part of United Hayek Industries Manufacturing Ltd

Devices
2
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What United Hayek Industries (Manufacturing) Limited makes

United Hayek Industries manufactures negative-pressure ventilators, including time-cycled and pressure-limited models designed for respiratory support in clinical settings. Their portfolio includes devices like the Hayek RTX and the Hayek Oscillator, which are intended for use in both acute and critical care environments.

The company’s devices are classified as Class II under regulatory frameworks, with products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

Company details

DUNS number
211319456

FDA establishments1

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

  • United Hayek Industries Manufacturing Ltd London Barnet · GB FEI 3008808130

Frequently asked questions

How many devices does UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED have in the registry?

The registry currently lists 2 devices for UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED. Devices recorded under merged duplicate company entries are counted once.

Which registries list UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED's devices?

Among its 2 most recently registered devices, UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED has devices listed in FDA GUDID (2 devices).

What risk classes do UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED's devices fall under?

Among its 2 most recently registered devices, the classes recorded for UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED in the registry?

The most recently registered devices listed for UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED include Hayek RTX 01 and Hayek Oscillator HOSC-01.

Which FDA establishments are linked to UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED?

1 FDA establishment is linked to UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED in the registry; they are listed on the company page.

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