EU → US Device Access

LMT Medical Systems GmbH

DE-MF-000005238 · Germany · Lübeck

LMT Medical Systems GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11
Class IIb2

Among these devices, 13 are declared active, 2 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLMT MEDICAL SYSTEMS GMBH (DE) · FDA 3009514037
Devices in EUDAMED13
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G10 087909 0012issued2026-07-26

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