EU → US Device Access

Timago International Group Ossowski Spółka komandytowa

PL-MF-000004105 · Poland · Bielsko-Biała

Timago International Group Ossowski Spółka komandytowa is registered in the European database on medical devices as a manufacturer, with 138 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa138

Most frequent device types declared: T101, H011, TGO-C SK-O 504, DRIFT-TIM, TGO-C OB 306.

Among these devices, 3 are declared 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 EUDAMED138
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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