FDA Device Establishments · JSON-LD · Markdown
FEI 3007244127 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3007244127 |
|---|---|
| Owner / Operator | IntroMedic Co., Ltd. (#10027343) |
| Address | Suite 1105 1106 E&C Venture Dream Tower 6-Cha, Guro Dong, Guro Gu, Seoul, 152-719, 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 | MiroCam Receiver: MR1100; MiroCam Capsule: MC1000-B; Data Cable: MR1000-D; MiroCam Capsule Endoscope System; Data Belt: MR1000-D(M), MR1000-D(L); MiroView Software: MiroView U, MiroView RTV, MiroView RTV-i |
Source: openFDA. Public-domain (CC0).