EU → US Device Access

Thermo Fisher Scientific Oy

FI-MF-000001479 · Finland · Vantaa

Thermo Fisher Scientific Oy is registered in the European database on medical devices as a manufacturer, with 258 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other258

Most frequent device types declared: INDIKO.

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 registerRegistered with FDA
Matched entryTHERMO FISHER SCIENTIFIC OY (FI) · FDA 9610942
Devices in EUDAMED258
Country of registrationFinland

Notified body certificates

CertificateStatusExpiry
HX 1070846-1supplemented2028-01-31

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