FDA Device Establishments · JSON-LD · Markdown
FEI 3007699074 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3007699074 |
|---|---|
| Owner / Operator | Sartorius Stedim North America Inc./Sartorius Corporation (#9005426) |
| Address | Sperry Way, Stonehouse Park, Stonehouse Gloucestershire, GL10 3UT, GB |
| Mandatory US Agent | Sartorius Stedim North America Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJH |
| Regulation § (21 CFR) | 862.2310 |
| Proprietary names | Vivaspin 6 (VS0601IVD, VS0602IVD); Vivaspin 15 Turbo (VS15T01IVD, VS15T02IVD); Vivaspin 4 Turbo (VS04T01IVD, VS04T02IVD); Vivafree 500 30K (VFR01H21,VFR01H22,VFR01H23); Vivafree 500 125K (VFR01H81,VFR01H82,VFR01H83); Vivaspin 20 (VS2001IVD, VS2002IVD); Centrisart 100k (13269----------E); Vivafree 2 125K (VFR02H81,VFR02H82,VFR02H83); Vivapore 5 (VP0503, VP0501); Vivaspin 4 10K (VS0404, VS0405) |
Source: openFDA. Public-domain (CC0).