EU → US Device Access

Astek Innovations Ltd

GB-MF-000013346 · United Kingdom · Altrincham

Astek Innovations Ltd is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa33

Most frequent device types declared: 16499, 11650UNODENT.

Authorised representative in the Union: IE-AR-000011249.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED33
Country of registrationUnited Kingdom
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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