FDA Device Establishments · JSON-LD · Markdown
FEI 3012402886 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3012402886 |
|---|---|
| Owner / Operator | Exact Imaging, Inc. (#10053728) |
| Address | 7676 Woodbine Avenue, Unit 15, Markham Ontario, L3R 2N2, CA |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | IYN, IYO, OIJ, ITX |
| Regulation § (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Proprietary names | EV5C Abdominal Transducer; EV29L Sterile Transrectal Needle Guide; EV29L High Resolution Side-Fire Transducer; EV9C Transrectal End-Fire Transducer; EV29L Non-Sterile Reusable Transrectal Needle Guides; ExactVu High Resolution Micro-Ultrasound System |
Source: openFDA. Public-domain (CC0).