FDA Device Establishments · JSON-LD · Markdown
FEI 3007343307 · Manufacture Medical Device · Status: Active
| FEI Number | 3007343307 |
|---|---|
| Owner / Operator | DA TECH CO LTD (#10027379) |
| Address | 13, Seounsandan-ro 4-gil, Gyeyang-gu, Incheon, 21072, KR |
| Mandatory US Agent | KHN Solutions, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DJZ |
| Regulation § (21 CFR) | 862.3050 |
| Proprietary names | BACTRACK S80; BACTRACK S82; BACTRACK S75; BACTRACK Element; BACTRACK S78 |
Source: openFDA. Public-domain (CC0).