FDA Device Establishments · JSON-LD · Markdown
FEI 3015002281 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3015002281 |
|---|---|
| Owner / Operator | OrbusNeich Medical Co. Ltd (Hong Kong) (#10059958) |
| Address | Units 303 &305, 3/F, Building 20E, Hong Kong Science Park, Shatin, N.t., Hong Kong, No. 27-31 Au Pui Wan Streeet, Fo Tan, N.T., NA, HK |
| Mandatory US Agent | OrbusNeich Medical, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | LIT, LOX |
| Regulation § (21 CFR) | 870.1250, 870.5100 |
| Proprietary names | Sapphire II Pro Coronary Dilatation Catheter |
Source: openFDA. Public-domain (CC0).