EU → US Device Access

PARI GmbH Spezialisten für effektive Inhalation

DE-MF-000006567 · Germany · Starnberg

PARI GmbH Spezialisten für effektive Inhalation is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa46

Most frequent device types declared: VORTEX > 4 years, PARI masks soft, PARI BABY Masks, PARI O-PEP, PARI SMARTMASK.

Among these devices, 3 are declared active.

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 EUDAMED46
Country of registrationGermany
⚠️ 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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