FDA Device Establishments · JSON-LD · Markdown
FEI 3010952064 · Manufacture Medical Device · Status: Active
| FEI Number | 3010952064 |
|---|---|
| Owner / Operator | CHUNGWOO CO., LTD. (#10087784) |
| Address | (Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro, Geumcheon-gu Seoul, 08591, KR |
| Mandatory US Agent | KMC USA, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEI |
| Regulation § (21 CFR) | 878.4400 |
| Proprietary names | Mono-polar Hand piece (Model: CWM-930S-Y03); Sterile Micro Needle ELLISYS ST (Model: CWM-930S_ELLISYS ST-S36); Bi-polar Hand piece Suction Filter (Model: CWM-930S-Y02); Neutral Pad (Model: 9571C); Foot Switch (Model: CWM-930S-H13); Neutral Cable (Model: CWM-930S-H37); Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C49, CWM-930S_ELLISYS ST-S49); Bi-polar Hand piece (Model: CWM-930S-Y01); ELLISYS SENSE (Model: CWM-930S); FIXER DV9 (Model: CWM-930S) |
Source: openFDA. Public-domain (CC0).