FDA Device Establishments · JSON-LD · Markdown
FEI 3010806663 · Manufacture Medical Device · Status: Active
| FEI Number | 3010806663 |
|---|---|
| Owner / Operator | Inoris Medical Sp. z o.o. (#10046303) |
| Address | ul. Zmkowa 9, Kowary Dolnoslaskie, 58530, PL |
| Mandatory US Agent | KAL-MED, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MNK |
| Regulation § (21 CFR) | 876.1500 |
| Proprietary names | Pediatric Biteguard; Tubeguard; Scanhead protection cover; Gastroguard; Adult Biteguard; Clip-On Biteguard; Soft Adult Biteguard |
Source: openFDA. Public-domain (CC0).