EU → North America Device Access

Metrax GmbH

DE-MF-000005478 · Germany · Rottweil

Metrax GmbH is registered in the European database on medical devices as a manufacturer, with 306 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4
Class I296
Class IIa6

Among these devices, 1 are declared sterile, 300 active.

Devices declared under this manufacturer

Showing 12 of 306 declared devices.

Catalogue references include 74254, 74569, 97640, 97916, 97924, 98032.

European nomenclature codes declared: Z12030501, Z12030503, C020401, Z12030501,Z12030503, C020480.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED306
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 GTIN302
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. Metrax GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
G70 023787 0039issued2030-05-11
G70 023787 0036issued2030-03-16

Other manufacturers in Germany

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