FDA Device Establishments · JSON-LD · Markdown
FEI 3013206323 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3013206323 |
|---|---|
| Owner / Operator | Integration Diagnostics Sweden AB (#10054105) |
| Address | Furstenbergsgatan 4, Goteborg Vastra Gotaland, 41664, SE |
| Mandatory US Agent | NSK America Corporation |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EKX |
| Regulation § (21 CFR) | 872.4200 |
| Proprietary names | IS3; Penguin RFA; MulTipeg Driver; MulTipeg; Osseo 100; IS4; Locking screwdriver; Penguin II; MDI MulTipeg; Osseo 100+ |
Source: openFDA. Public-domain (CC0).