EU → North America Device Access

Eduard Gerlach GmbH

DE-MF-000006590 · Germany · Lübbecke

Eduard Gerlach GmbH is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa38

Most frequent device types declared: VHO-OSTHOLD-SCHLAUFE, VHO-OSTHOLD-Spange Mezzo 0,3 mm.

Devices declared under this manufacturer

Showing 12 of 38 declared devices.

Catalogue references include 313280302, 313290302, 313290402, 363381066, 363381077, 363382055.

European nomenclature codes declared: Y061299, Z12139004.

United States market access

FDA establishment registerRegistered with FDA
Matched entryEduard Gerlach Gmbh (DE) · FDA 3004632523
Devices in EUDAMED38
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN36
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: United States only. Eduard Gerlach GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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