EU → US Device Access

Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna

PL-MF-000015608 · Poland · Lublin

Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa40

Among these devices, 36 are declared 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 EUDAMED40
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
TNP/MDR/0024/0052/2024issued2027-09-05

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