EU → North America Device Access

PARI Pharma GmbH

DE-MF-000006193 · Germany · Starnberg

PARI Pharma GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: PARI SMARTMASK Kids, PARI SMARTMASK Baby.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include 078G5001, 078G5026, 078G5028, 678B4020, 678B4060, 678B4090.

European nomenclature codes declared: R060101, R03010301, R0680.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN10
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. PARI Pharma GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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