EU → US Device Access

W & H Dentalwerk Bürmoos GmbH

AT-MF-000001590 · Austria · Bürmoos

W & H Dentalwerk Bürmoos GmbH is registered in the European database on medical devices as a manufacturer, with 452 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa452

Most frequent device types declared: 10114403, 30310000, 00030135, 30061000, SI-923.

Among these devices, 25 are declared sterile, 99 reusable, 325 active.

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 EUDAMED452
Country of registrationAustria
⚠️ 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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