FDA Device Establishments · JSON-LD · Markdown
FEI 3003898328 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3003898328 |
|---|---|
| Owner / Operator | BANDAGE-EN CORSETINDUSTRIE BASKO B.V. (#9053038) |
| Address | PIETER LIEFTINCKWEG 16, ZAANDAM Noord-Holland, 1505 HX, NL |
| Mandatory US Agent | Fillauer LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IOZ |
| Regulation § (21 CFR) | 890.3665 |
| Proprietary names | Dynamic hip abduction orthosis for children; Pavlik harness |
Source: openFDA. Public-domain (CC0).