EU → US Device Access

MACHEREY-NAGEL GmbH & Co. KG

DE-MF-000005636 · Germany · Düren

MACHEREY-NAGEL GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other88

Most frequent device types declared: Medi-Test URYXXON® Stick 10, Uralyt-U® pH 5.6-8.0, URYXXON® Relax, Medi-Test Glucose, NucleoSpin® Dx Blood.

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 entryMACHEREY-NAGEL GMBH & CO., KG. (DE) · FDA 4580
Devices in EUDAMED88
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
IX 1038121-4issued2028-05-15
IX 1038121-3issued2028-05-15
IX 1038121-2issued2028-05-15
IX 1038121-1issued2028-05-15
HX 1038121-1issued2028-05-15

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