EU → US Device Access

S.G.S. International Kft

HU-MF-000007066 · Hungary · Budapest

S.G.S. International Kft is registered in the European database on medical devices as a manufacturer, with 699 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb699

Most frequent device types declared: STCSD without hex-0.35mm, P7D-4.2-16mm, P1-4.2-8mm, SIB-3.75-KV, P7N-3.0-13mm.

Among these devices, 267 are declared sterile, 697 implantable, 2 active, 6 with a measuring function.

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 entryS.G.S. INTERNATIONAL LTD (HU) · FDA 3011545243
Devices in EUDAMED699
Country of registrationHungary

Other manufacturers in Hungary

All Hungary manufacturers →