FDA Device Establishments · JSON-LD · Markdown
FEI 3010501626 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3010501626 |
|---|---|
| Owner / Operator | GEV Co., Ltd. (#10043696) |
| Address | 37-10, Maengdongsandan-ro, Maengdong-myeon, Eumseong-gun Chungbuk, 27733, KR |
| Mandatory US Agent | Hans Biomed USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | MBP, MQV |
| Regulation § (21 CFR) | 888.3045 |
| Proprietary names | SurFuse |
Source: openFDA. Public-domain (CC0).