FDA Device Establishments · JSON-LD · Markdown
FEI 3015462350 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3015462350 |
|---|---|
| Owner / Operator | SKY Medical, a.s. (#10060326) |
| Address | Vicenzy 24/2058, Samorin Trnavsky, 931 01, SK |
| Mandatory US Agent | ProMedic Consulting LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ONB |
| Regulation § (21 CFR) | 880.5440 |
| Proprietary names | Closed antineoplastic and hazardous drug reconstitution and transfer system |
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