EU → North America Device Access

IVF HARTMANN AG

CH-MF-000015962 · Switzerland · Neuhausen

IVF HARTMANN AG is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa45

Most frequent device types declared: 1422, 1498, 1499, 2244, 3206.

Among these devices, 6 are declared sterile.

Authorised representative in the Union: PAUL HARTMANN AG.

Devices declared under this manufacturer

Showing 12 of 45 declared devices.

Catalogue references include 521021, 521321, 528050, 550211, 550301, 550321.

European nomenclature codes declared: M040204, M04010199, M050199, M03030299, M030599, M0304010103.

United States market access

FDA establishment registerRegistered with FDA
Matched entryIVF HARTMANN AG (CH) · FDA 8031008
Devices in EUDAMED45
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN45
Found in the U.S. device database3
Share6.7 %

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: United States only. IVF HARTMANN AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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