EU → North America 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

Most frequent device types declared: INDIKO.

Devices declared under this manufacturer

Showing 12 of 258 declared devices.

Catalogue references include 10018775, 952050, 981593, 981679, 981798, 981852.

European nomenclature codes declared: W02060101, W02060102, W0102152209, W0102152006, W0101050299, W0102152003.

United States market access

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

Device-level evidence

Devices with a numeric GTIN248
Found in the U.S. device database39
Share15.7 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryTHERMO FISHER SCIENTIFIC

North American profile: Both markets. Thermo Fisher Scientific Oy is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
HX 1070846-1supplemented2028-01-31

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