FDA Device Establishments · JSON-LD · Markdown
FEI 3013734919 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3013734919 |
|---|---|
| Owner / Operator | The Standard Co., Ltd. (#10055479) |
| Address | 120, Gunpocheomdansaneop 2-ro, Gunpo-si Gyeonggi, 15880, KR |
| Mandatory US Agent | LK Consulting Group USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | GEX, PBX |
| Regulation § (21 CFR) | 878.4810, 878.4400 |
| Proprietary names | A-FIT |
Source: openFDA. Public-domain (CC0).