Data / Medical devices / Slovakia / SKY Medical, a.s.
SKY Medical, a.s.: FDA-registered device maker in Samorin Trnavsky, Slovakia, 1 510(k) clearance
SKY Medical, a.s. is registered with the FDA (registration 3015462350) in Samorin Trnavsky, Slovakia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015462350
- Address
- Vicenzy 24/2058, Samorin Trnavsky, Slovakia, 931 01
- Owner or operator
- SKY Medical, a.s. (10060326)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 21, 2022
- Registered through
- 2026
- Brand names listed
- Closed antineoplastic and hazardous drug reconstitution and transfer system, Extension Feeding Set with ENFit connectors, Medicina Extension Feeding Set with ENFit connectors
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Contract manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 18, 2025 | K250481 | Extension Feeding Set with ENFit Connectors | PIF | Substantially Equivalent | SKY Medical, a.s. | accessdata.fda.gov |
Compare with other makers
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
Updated April 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.