EU → North America Device Access

APIRO Diagnostics Kft.

HU-MF-000043501 · Hungary · Budaörs

APIRO Diagnostics Kft. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: 1021EU, 1031EU, 1041EU, 1051EU, 1061EU.

Devices declared under this manufacturer

Catalogue references include 1021EU, 1031EU, 1041EU, 1051EU, 1061EU, 2011EU.

European nomenclature codes declared: W01030299, W0103020702, W0202029085.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationHungary

⚠️ 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. APIRO Diagnostics Kft. was not found in either the U.S. or the Canadian register.

Other manufacturers in Hungary

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