EU → US Device Access

ZARYS International Spółka z ograniczoną odpowiedzialnością

PL-MF-000000410 · Poland · Zabrze

ZARYS International Spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 1 303 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 302
Class I1

Most frequent device types declared: OP-OPA-00130, OP-CES-02815, OP-CHI-00522, OP-LAP-00842, OP-ORT-01324.

Among these devices, 747 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 EUDAMED1 303
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.

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