EU → US Device Access

PANEP s.r.o.

CZ-MF-000033142 · Czechia · Rosice

PANEP s.r.o. is registered in the European database on medical devices as a manufacturer, with 202 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa202

Among these devices, 173 are declared sterile.

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 EUDAMED202
Country of registrationCzechia
⚠️ 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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