EU → US Device Access

KAZ Europe Sàrl

CH-MF-000029980 · Switzerland · Bussigny, Vaud

KAZ Europe Sàrl is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa61

Most frequent device types declared: IRT6520 / IRT6525 / IRT6575, IRT3030 / IRT3515, BUA4000 / BUA4050, Braun ExactFit 3 BUA6150 / Braun ExactFit 5 Connect, BUA6350, Braun High Speed Thermometer, PRT1000.

Among these devices, 55 are declared active, 53 with a measuring function.

Authorised representative in the Union: BE-AR-000000106.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED61
Country of registrationSwitzerland
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
1000305898supplemented2029-07-29

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