FDA Device Establishments · JSON-LD · Markdown
FEI 3008386587 · Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3008386587 |
|---|---|
| Owner / Operator | Auditdata A/S (#10032598) |
| Address | Wildersgade 10B, Copenhagen Hovedstaden, 1408, DK |
| Mandatory US Agent | Auditdata LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ERA |
| Regulation § (21 CFR) | 874.4770 |
| Proprietary names | 2001 Primus Video Otoscope - PVO |
Source: openFDA. Public-domain (CC0).