EU → US Device Access

AET Australasian European Trading GmbH

DE-MF-000009115 · Germany · Au in der Hallertau

AET Australasian European Trading GmbH is registered in the European database on medical devices as a manufacturer, with 76 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa76

Most frequent device types declared: knee orthoses with stays, prescribable, Wrist support active, not prescribable, Knee brace without stays, active, not prescribable, wrist orthoses, prescribable, Lumbar brace not prescribable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED76
Country of registrationGermany
⚠️ 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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