EU → North America Device Access

Tyromotion GmbH

AT-MF-000016168 · Austria · Graz

Tyromotion GmbH is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa15

Most frequent device types declared: 3, 6, G1, G5, G6.

Among these devices, 15 are declared active.

Devices declared under this manufacturer

Showing 12 of 15 declared devices.

Catalogue references include 11920, 12906, 15213, 15425, 15426, 15703.

European nomenclature codes declared: Z12069099, Z12069080, Z12069002, Z12069092.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTYROMOTION GMBH (AT) · FDA 3008887767
Devices in EUDAMED15
Country of registrationAustria

Device-level evidence

Devices with a numeric GTIN15
Found in the U.S. device database10
Share66.7 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryTYROMOTION GMBH

North American profile: Both markets. Tyromotion GmbH is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
22M00079CRT01issued2030-04-16

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