FDA Device Establishments · JSON-LD · Markdown
FEI 3013328880 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3013328880 |
|---|---|
| Owner / Operator | Bone Index Finland Ltd. (#10052487) |
| Address | Savilahdentie 14, Kuopio Pohjois-Savo, 70700, FI |
| Mandatory US Agent | Dawa Medical LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MUA |
| Regulation § (21 CFR) | 892.1180 |
| Proprietary names | Bindex BI-2 Kit v2 (w/o Gel); Bindex BI-2 Kit v1 (w/ Gel); Bindex BI-2 Kit v3 (w/o Gel); Bindex BI-2 Kit v4 (w/o Gel); Bindex Measure BI-41; Bindex BI-2 |
Source: openFDA. Public-domain (CC0).