EU → North America Device Access

PB Swiss Tools AG

CH-MF-000040741 · Switzerland · Wasen/Bern

PB Swiss Tools AG is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa19

Among these devices, 9 are declared sterile.

Authorised representative in the Union: MDSS GmbH.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include 80001, 80002, 80006, 80009, 80028, 80030.

European nomenclature codes declared: L091001, P091399, V9012.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPB SWISS TOOLS AG (CH) · FDA 3013043133
Devices in EUDAMED19
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN19
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. PB Swiss Tools AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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