FDA Device Establishments · JSON-LD · Markdown
FEI 3003775186 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3003775186 |
|---|---|
| Owner / Operator | ORBUSNEICH MEDICAL CO. LTD (HONG KONG) (#9050384) |
| Address | No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China;, Floor 1 and Floor 3, Tower D, Tong'an industrial park, No.124, Yonghe Rd., Baoan, Shenzhen, China, SHENZHEN Guangdong, 518038, CN |
| Mandatory US Agent | OrbusNeich Medical, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DQY |
| Regulation § (21 CFR) | 870.1250 |
| Proprietary names | Teleport Glide Microcatheter |
Source: openFDA. Public-domain (CC0).