EU → North America Device Access

Lang-Stereotest AG

CH-MF-000029998 · Switzerland · Küsnacht

Lang-Stereotest AG is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Authorised representative in the Union: Annemarie Lang-Lieder.

Devices declared under this manufacturer

Catalogue references include REF 103, REF 104, REF 501, REF 801, REF 802, REF 901.

European nomenclature codes declared: Q0209.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLANG-STEREOTEST AG (CH) · FDA 3003775438
Devices in EUDAMED6
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN6
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: United States only. Lang-Stereotest AG is registered in the United States but was not found in the Canadian register.

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