FDA Device Establishments · JSON-LD · Markdown
FEI 3015766032 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3015766032 |
|---|---|
| Owner / Operator | OPUM TECHNOLOGIES SERVICES LIMITED (#10089032) |
| Address | University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket, Auckland, 1023 , N, Khyber Pass Road,, Newmarket Auckland, 1023, NZ |
| Mandatory US Agent | OPUM US INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KQX |
| Regulation § (21 CFR) | 888.1500 |
| Proprietary names | Digital Knee Sensor DK-017; Digital Knee DK-012; Digital Knee DK-011; Digital Knee DK-008; Digital Knee DK-014; Digital Knee DK-009; Digital Knee DK-013; Digital Knee DK-010; myDigitalKnee App; Digital Knee DK-015 |
Source: openFDA. Public-domain (CC0).