EU → North America Device Access

Laserneedle GmbH

DE-MF-000023539 · Germany · Berlin

Laserneedle GmbH is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: 40600, LASERNEEDLE Touch Allround, LASERNEEDLE Touch Dental, LASERNEEDLE Touch OrthoPhys, LASERNEEDLE Touch Solution.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 10000, 12000, 13001, 15000, 40110, 40410.

European nomenclature codes declared: Z129099, Z120615, M0599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN22
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: Neither register. Laserneedle GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →