EU → US Device Access

APOLLO IMPLANT COMPONENTS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

PL-MF-000023711 · Poland · Pabianice

APOLLO IMPLANT COMPONENTS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 298 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa297
Class IIb1

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 EUDAMED298
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 2607846-1supplemented2028-12-19

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