FDA Device Establishments · JSON-LD · Markdown
FEI 3017004860 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3017004860 |
|---|---|
| Owner / Operator | Radisen Co Ltd (#10079944) |
| Address | B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu, Anyang Gyeonggi, 14058, KR |
| Mandatory US Agent | Mtech Group LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MQB |
| Regulation § (21 CFR) | 892.1680 |
| Proprietary names | PEDRA-1417MG Digital Flat Panel X-ray Detector; PEDRA-1417MC Digital Flat Panel X-ray Detector |
Source: openFDA. Public-domain (CC0).