FDA Device Establishments · JSON-LD · Markdown
FEI 3033043422 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3033043422 |
|---|---|
| Owner / Operator | Novanta Medical GmbH (#9004880) |
| Address | Pardubicka 1571, Prelouc Pardubicky Kraj, 535 01, CZ |
| Mandatory US Agent | NOVANTA MEDICAL USA, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | GCJ, HIF |
| Regulation § (21 CFR) | 876.1500, 884.1730 |
| Proprietary names | AirSeal iFS System |
Source: openFDA. Public-domain (CC0).