Diawin s.r.o.
SK-MF-000048596 · Slovakia · Košice
Diawin s.r.o. is registered in the European database on medical devices as a manufacturer, with 825 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 825 |
|---|
Most frequent device types declared: Cloudy Orchid, DIAWIN-D3-PURE, DIAWIN-D3-SERENE, Deep Motion, Inspo BW.
Catalogue references include AF16422, AF17383, AF371, AM27442, FF45483, FM42391.
European nomenclature codes declared: Y063303, Y061203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 825 |
| Country of registration | Slovakia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 825 |
|---|---|
| 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. Diawin s.r.o. was not found in either the U.S. or the Canadian register.