SGM d.o.o.
HR-MF-000029379 · Croatia · Split
SGM d.o.o. is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 35 |
|---|
Among these devices, 35 are declared sterile.
Devices declared under this manufacturer
- Corkscrew Electrode CS-F (1,0m)
- Corkscrew Electrode CS-F (1,5m)
- Hook Wire Electrode (0,4 m) 13mm
- Needle Electrode N-F (1,5 m) L07mm
- Needle Electrode N-F (1,5 m) L12mm
- Needle Electrode N-F (1,5 m) L18mm
- Paired Hook Wire Electrode (0,4 m) 30mm
- Paired Hook Wire Electrode (0,4 m) 50mm
- Paired Hook Wire Electrode (0,4 m) 80mm
- Triple Twisted Needle Electrode (1,5 m) L18mm
- Twisted Pair Needle Electrode TPN-F (2,0 m) L12mm
- Twisted Pair Needle Electrode TPN-F (2,0 m) L18mm
Showing 12 of 35 declared devices.
Catalogue references include N-07-15-24-C6, N-18-15, PHW-30-40-05-11, PHW-50-40-06-11, PHW-80-40-06-11, TPN-07-20.
European nomenclature codes declared: N010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 35 |
| Country of registration | Croatia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 35 |
|---|---|
| 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: Neither register. SGM d.o.o. was not found in either the U.S. or the Canadian register.