EU → North America Device Access

TRATE AG

CH-MF-000019071 · Switzerland · Root

TRATE AG is registered in the European database on medical devices as a manufacturer, with 1 172 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb759
Class IIa413

Most frequent device types declared: Dental Implant, ROOTT S, Dental implant, ROOTT BS, Dental implant, ROOTT M, Dental implant, ROOTT P, Dental implant, ROOTT R.

Among these devices, 543 are declared sterile, 759 implantable, 413 reusable.

Authorised representative in the Union: Trate UAB.

Devices declared under this manufacturer

Showing 12 of 1 172 declared devices.

Catalogue references include B3524ss, C3016ms, C3524mp, C5004m, C6006m, GFM4.

European nomenclature codes declared: P01020101, L99, P01020180.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTRATE UAB (LT) · FDA 3031529635
Devices in EUDAMED1 172
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN1 172
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. TRATE AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

All Switzerland manufacturers →