EU → US Device Access

medK GmbH

DE-MF-000006273 · Germany · Münster

medK GmbH is registered in the European database on medical devices as a manufacturer, with 339 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I176
Class IIa163

Most frequent device types declared: MedK Diagnostic Guidewires, MedK Hydrophilic Guidewires, MedK Y-Connectors and Sets, MedK Cardiovascular Guidewires, MedK Introducer Sets.

Among these devices, 339 are declared sterile, 18 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 registerNot found in the FDA register
Devices in EUDAMED339
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
7289GB448260106supplemented2029-10-07
20610GB450260729supplemented2030-10-12

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