FDA Device Establishments · JSON-LD · Markdown
FEI 3017847628 · Manufacture Medical Device · Status: Active
| FEI Number | 3017847628 |
|---|---|
| Owner / Operator | HYUNDAI BIOLAND Co., Ltd. (#10078950) |
| Address | 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si Chungbuk, 28125, KR |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NPL |
| Regulation § (21 CFR) | 872.3930 |
| Proprietary names | OssGuide; OsteoFlex; XP-SEAL; OsseoSeal; TBS Dental; T-Gen; Oradapt |
Source: openFDA. Public-domain (CC0).