FDA Device Establishments · JSON-LD · Markdown
FEI 3011196543 · Repack or Relabel Medical Device Manufacture Medical Device · Status: Active
| FEI Number | 3011196543 |
|---|---|
| Owner / Operator | Empatica S.r.l. (#10047497) |
| Address | Level 9, 31 Queen Street, Melbourne Victoria, 3000, AU |
| Mandatory US Agent | Empatica Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | GYD, NXQ, ISD |
| Regulation § (21 CFR) | 882.1950, 890.5050, 890.5360 |
| Proprietary names | Personal KinetiGraph (PKG) System; PKG |
Source: openFDA. Public-domain (CC0).