Sky Medical a.s.
SK-MF-000001475 · Slovakia · Samorin
Sky Medical a.s. is registered in the European database on medical devices as a manufacturer, with 1 422 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 933 |
|---|---|
| Class IIa | 489 |
Among these devices, 1 422 are declared sterile, 70 active, 70 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 register | Registered with FDA |
|---|---|
| Matched entry | SKY Medical, a.s. (SK) · FDA 3015462350 |
| Devices in EUDAMED | 1 422 |
| Country of registration | Slovakia |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1450762 1 | supplemented | 2027-11-22 |