EU → North America Device Access

4bases SA

CH-MF-000042125 · Switzerland · Manno

4bases SA is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: Barcode Set, Index Set, UDI Primers Set, WES pro.

Authorised representative in the Union: 4bases Italia srl.

Devices declared under this manufacturer

Catalogue references include 3006, 7001, 7002, 7003, 7004, 7005.

European nomenclature codes declared: W01060299, W010699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. 4bases SA was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

All Switzerland manufacturers →