EU → US Device Access

Vimex Sp. z o.o.

PL-MF-000008668 · Poland · Gliwice

Vimex Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa54

Among these devices, 41 are declared sterile, 2 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 EUDAMED54
Country of registrationPoland
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
HZ 1023639-1supplemented2029-10-24

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