EU → North America Device Access

Clinomic Medical GmbH

DE-MF-000013339 · Germany · Aachen

Clinomic Medical GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: Mona Terminal, MonaOS 2, MonaOS 3.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include 6, Mona Terminal 1.1 series 0.1, Mona Terminal 1.1 series 0.2, Mona Terminal 1.1 series 0.3, Mona Terminal 2.0 series 0.1, MonaOS 2.

European nomenclature codes declared: Z1203020201, Z12030201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN6
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: Neither register. Clinomic Medical GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
G15 110050 0004issued2028-01-25
G10 110050 0002issued2028-01-25

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