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 IIb | 699 |
|---|
Most frequent device types declared: H-S16S/S17S, HNN-2.1-2mm, P1-4.2-8mm, P5G-4.2-8mm, P7D-4.2-16mm.
Among these devices, 267 are declared sterile, 697 implantable, 2 active, 6 with a measuring function.
Devices declared under this manufacturer
- P1-4.2-8mm
- P1D-3.75-11.5mm
- P1D-4.2-6mm
- P1D-5.0-13mm
- P5G-4.2-8mm
- P5G-6.0-16mm
- P7-6.0-16mm
- P7D-3.5-10mm
- P7D-3.5-13mm
- P7D-4.2-16mm
- P7D-4.2-6mm
- P7D-5.0-16mm
Showing 12 of 699 declared devices.
Catalogue references include D034216, D109S035, G09428, M01428, N04313, N10382.
European nomenclature codes declared: P01020180, P01020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | S.G.S. INTERNATIONAL LTD (HU) · FDA 3011545243 |
| Devices in EUDAMED | 699 |
| Country of registration | Hungary |
Device-level evidence
| Devices with a numeric GTIN | 699 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. S.G.S. International Kft is registered in the United States but was not found in the Canadian register.