EU → US Device Access

CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente

AT-MF-000001504 · Austria · Wien

CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente is registered in the European database on medical devices as a manufacturer, with 175 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa173
Class IIb2

Most frequent device types declared: Jet Laryngoscopes and Jet Tracheoscopes, Jet Bronchoscopes and Jet Tracheo Bronchoscopes, Cleaning Adaptors, Supporting Arm Adaptors, Jet Catheter.

Among these devices, 19 are declared sterile, 2 active, 2 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED175
Country of registrationAustria
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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