EU → North America Device Access

retec Kunststofftechnik GmbH

DE-MF-000000086 · Germany · Rosbach

retec Kunststofftechnik GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: Acrylics for the manufacture of dentures, Kunststoffe zur Herstellung von Prothesenkunststoffen.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include AX-1-301-150-02, AX-1-701-100-43, AX-1-701-100-44, AX-1-702-050, SHE-505010, SHE-508080.

European nomenclature codes declared: Q010699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
Country of registrationGermany

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

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. retec Kunststofftechnik GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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