EU → North America Device Access

LAP GmbH Laser Applikationen

DE-MF-000005792 · Germany · Lüneburg

LAP GmbH Laser Applikationen is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa67
Class IIb8

Among these devices, 73 are declared active.

Devices declared under this manufacturer

Showing 12 of 75 declared devices.

Catalogue references include 0012206-0006, 0013821, 0014088, 0014640-0004, 0014640-0016, 0015562-0001.

European nomenclature codes declared: Z119010, Z119099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLAP GMBH LASER APPLIKATIONEN (DE) · FDA 9681134
Devices in EUDAMED75
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN75
Found in the U.S. device database62
Share82.7 %

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. LAP GmbH Laser Applikationen is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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