EU → North America Device Access

MT MonitorTechnik GmbH & Co. KG

DE-MF-000005317 · Germany · Hannover

MT MonitorTechnik GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa18
Class IIb8

Among these devices, 8 are declared active, 8 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 26 declared devices.

Catalogue references include EK-0302, EK-0306, EK-0310, EK-0311, EK-0314, EK-0315.

European nomenclature codes declared: Z12100380, Z12100302, Z12030292, N01010299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMT MONITORTECHNIK GMBH & CO. KG (DE) · FDA 3004203820
Devices in EUDAMED26
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN26
Found in the U.S. device database4
Share15.4 %

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. MT MonitorTechnik GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
3561GB448250923amended2028-08-30

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