EU → North America 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: BNA050EU / BNF020EU, BNA100, BUA4000 / BUA4050, Braun High Speed Thermometer, PRT1000, Braun Sensian 5 Thermometer, BNT300 / Braun Sensian 7 Thermometer, BNT.

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

Authorised representative in the Union: Obelis s.a..

Devices declared under this manufacturer

Showing 12 of 61 declared devices.

Catalogue references include BNT300EE, BNT400WE, IRT3030WE, IRT3515WE, IRT6515MNLA, IRT6515NOEE / IRT6520WE, IRT6520BWE, IRT6520NOEE, IRT6520, IRT6520NOEE.

European nomenclature codes declared: V0301010201, Z1203020302, V0301010201,V0301010202, V028099, V0299, V030180.

United States market access

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

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN52
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. KAZ Europe Sàrl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
1000305898supplemented2029-07-29

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