EU → North America Device Access

Max Stäubli AG

CH-MF-000013911 · Switzerland · Horgen

Max Stäubli AG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: Katheterventile, Schneerohr.

Among these devices, 5 are declared sterile.

Authorised representative in the Union: MED-RAS GmbH Regulatory Affairs Service.

Devices declared under this manufacturer

Catalogue references include 300000ST, 300100ST, 300101ST, 300102ST, 300200ST, VDV001.

European nomenclature codes declared: U0180, Q0199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. Max Stäubli AG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
170782451issued2028-06-29

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