FDA Device Establishments · JSON-LD · Markdown
FEI 3013684328 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3013684328 |
|---|---|
| Owner / Operator | IntroMedic Co., Ltd. (#10027343) |
| Address | F-RTEK 4F, 11-25, Simin-daero 327 beon-gil, Dongan-gu, Anyang-si Gyeonggi, 14055, KR |
| Mandatory US Agent | IntroMedic America Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NEZ |
| Regulation § (21 CFR) | 876.1300 |
| Proprietary names | MiroView Software: MiroView U 3, MiroView RTV, MiroView RTV-i; Data Belt: MR1000-D(S), MR1000-D(M), MR1000-D(L); MiroCam Capsule Endoscope System; MiroCam Receiver: MR1100; MiroCam Capsule: MC1200-B; Data Cable: MR1000-D |
Source: openFDA. Public-domain (CC0).