EU → US Device Access

Turon MedTech AB

SE-MF-000033162 · Sweden · Varberg

Turon MedTech AB is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa16

Among these devices, 7 are declared sterile.

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 entryTURON MEDTECH AB (SE) · FDA 3007335051
Devices in EUDAMED16
Country of registrationSweden

Notified body certificates

CertificateStatusExpiry
28620168400issued2028-10-29

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