EU → US Device Access

MARGOMED SPÓŁKA AKCYJNA

PL-MF-000009261 · Poland · Lublin

MARGOMED SPÓŁKA AKCYJNA is registered in the European database on medical devices as a manufacturer, with 215 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa210
other5

Most frequent device types declared: Infusion extension tubing, UV protected infusion extension tubing, LuxInject syringe, ProInject syringe, ASCOSET; UNI-ASCOSET , Medicine cup, Catheter syringe.

Among these devices, 207 are declared sterile, 37 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 EUDAMED215
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 2631342-1issued2030-04-24

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