EU → North America 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 has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa452

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

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

Devices declared under this manufacturer

Showing 12 of 452 declared devices.

Catalogue references include 02083500, 06067700, 10035502, 30104000, 30106000, 30326000.

European nomenclature codes declared: Z12110180, Z12119099, Z12019099, Z12119001, Z12119006.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryW&H DENTALWERK BUERMOOS GMBH (AT) · FDA 9681479
Devices in EUDAMED452
Country of registrationAustria

⚠️ A similar name exists; we do not assert it is the same company — why.

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryW&H DENTALWERK BURMOOS GMBH

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record38
Currently active0
Class 2 devices38
First licensed1998-09-24

Licence types: System (25), Device Family (10), Device Group Family (2), Device Group (1).

Licensed under: DENTAL HANDPIECE, IMPLANTMED, SURGICAL HANDPIECES, POWERED SURGICAL UNITS, AIR MOTORS, COUPLING.

Other manufacturers in Austria

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