EU → North America Device Access

Peter Lazic GmbH

DE-MF-000005519 · Germany · Tuttlingen

Peter Lazic GmbH is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa86

Catalogue references include 19.104.02, 35.028, 64.021.20, 64.999.02, 65.022, 70.268.02.

European nomenclature codes declared: V0499, L149004, K020180, L11050301, L0903, L03140199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPETER LAZIC GMBH (DE) · FDA 8010890
Devices in EUDAMED86
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN86
Found in the U.S. device database65
Share75.6 %

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. Peter Lazic GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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