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 IIa | 489 |
|---|---|
| Class IIb | 933 |
Among these devices, 1 422 are declared sterile, 70 active, 70 with a measuring function.
Devices declared under this manufacturer
- 18586021475335
- Extension Feeding Set with ENFitTM connectors
- For Enteral Feeding only. For use with Extension Feeding Set with ENFi
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit
- Physiological Pressure Transducer Sets
- Physiology Pressure Transducer Sets
- Tubing Systems and Accessories for Fluid Delivery
Showing 12 of 1 422 declared devices.
Catalogue references include CM-LS0002, GH183510TE, IV-S10008, IV-S20007, TP-SB1007, TP-SS0010.
European nomenclature codes declared: G02020201, A03040199, A03020102, A04010101, Z12030299, A03020101.
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 |
Device-level evidence
| Devices with a numeric GTIN | 1 422 |
|---|---|
| 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. Sky Medical a.s. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1450762 1 | supplemented | 2027-11-22 |