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KLS Martin SE & Co. KG

DE-MF-000005551 · Germany · Tuttlingen

KLS Martin SE & Co. KG is registered in the European database on medical devices as a manufacturer, with 213 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb80
Class I72
Class IIa61

Most frequent device types declared: 16-000-10.

Among these devices, 119 are declared sterile, 152 implantable, 8 reusable, 3 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 entryKLS MARTIN SE & CO. KG (DE) · FDA 3036795921
Devices in EUDAMED213
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
20486GB450260713supplemented2029-10-15
20452GB450250508issued2030-05-07

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