FDA Device Establishments · JSON-LD · Markdown
FEI 3017865161 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3017865161 |
|---|---|
| Owner / Operator | Pemax Kunststoff GmbH (#10079845) |
| Address | Curiestr. 2, Stuttgart Baden-Wurttemberg, 70563, DE |
| Mandatory US Agent | MEDAGENT Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PUI |
| Regulation § (21 CFR) | 878.4370 |
| Proprietary names | PC3-SCSA-3; HMD cover sterile No. 12364; Robotic scope sterile drape No. 13928; VB10-SC Smart Control Drape; PC3-VB10-3 6 clip Drape; PC2-SD-3; VB10-RC Remote Control Unit Drap Set; Robotic scope sterile drape No. 12364 |
Source: openFDA. Public-domain (CC0).