EU → US Device Access

LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.

HU-MF-000002846 · Hungary · Debrecen

LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa32

Most frequent device types declared: EC-2H System , EC-12S V6, EC-3H Holter Recorder, EC-12RM, EC-3H/ABP Recorder.

Among these devices, 32 are declared active, 32 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 EUDAMED32
Country of registrationHungary
⚠️ 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.

Other manufacturers in Hungary

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