EU → North America Device Access

Varian Medical Systems Particle Therapy GmbH & Co. KG

DE-MF-000005626 · Germany · Troisdorf

Varian Medical Systems Particle Therapy GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb10

Among these devices, 10 are declared active.

Devices declared under this manufacturer

Catalogue references include ProBeam 360° 1.0, ProBeam 360° 2.0, ProBeam 360° 3.0, ProBeam 4.3, ProBeam 4.3 MR4, ProBeam 4.3 MR6.

European nomenclature codes declared: Z11011001.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVarian Medical Systems Particle Therapy GmbH & Co. KG (DE) · FDA 3010658895
Devices in EUDAMED10
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database6
Share60.0 %

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. Varian Medical Systems Particle Therapy GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

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