EU → US Device Access

Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.

PL-MF-000009262 · Poland · Bydgoszcz

Zakład Techniki Medycznej "Tech-Med" Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 747 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa745
Class IIb2

Most frequent device types declared: TB, SK, PT, SR, PJ.

Among these devices, 2 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 EUDAMED747
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/0044/1127/2025supplemented2028-12-07
TNP/MDR/0004/1127/2022amended2025-12-07

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