FDA Device Establishments · JSON-LD · Markdown
FEI 3002808486 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3002808486 |
|---|---|
| Owner / Operator | WILLIAM COOK EUROPE APS (#9053266) |
| Address | SANDET 6, BJAEVERSKOV Sjalland, DK-4632, DK |
| Mandatory US Agent | Cook Medical Holdings |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KRD |
| Regulation § (21 CFR) | 870.3300 |
| Proprietary names | Flipper® Delivery System; MReye® Flipper® Detachable Embolization Coil |
Source: openFDA. Public-domain (CC0).