FDA Device Establishments · JSON-LD · Markdown
FEI 3010127792 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3010127792 |
|---|---|
| Owner / Operator | Sartorius Stedim North America Inc./Sartorius Corporation (#9005426) |
| Address | Tietokatu 4, Kajaani, Finland Kainuu, 87400, FI |
| Mandatory US Agent | Sartorius Stedim North America |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JRC |
| Regulation § (21 CFR) | 862.2050 |
| Proprietary names | Safetyspace Filter Tip 1200 µl (791211F); Optifit Tips 200 µl (790200, 790201, 790202, 790203, LH-B790204, LH-EB790204); Optifit Tips 1200 µl (791200, 791201, 791202, 791203, 791210, 791210, 791211, 791212, 791213, LH-B791204, LH-EB791204); Optifit Tips 10 µl (790010, 790011, 790012, 790013, 790014); Safetyspace Filter Tip 300 µl (790301F); Safetyspace Filter Tip 1000 µl (791001F); Optifit Tips 1000 µl (791000, 791001, 791002, 791003, 791020, 791021, LH-B791004, LH-B791024, LH-EB791004, LH-X791000, L; Picus2 8-ch (LH-747321, LH-747341, LH-747361, LH-747391); Mline 12-ch (725220, 725230, 725240); Mline 1-ch (725010, 725020, 725030, 725050, 725060, 725070, 725080, 725090) |
Source: openFDA. Public-domain (CC0).