FDA Device Establishments · JSON-LD · Markdown
FEI 3003800209 · Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3003800209 |
|---|---|
| Owner / Operator | Bien-Air Surgery SA (#10024150) |
| Address | rue de l Ouest 2b, Le Noirmont Jura, 2340, CH |
| Mandatory US Agent | BIEN AIR USA, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | HBC, HBE |
| Regulation § (21 CFR) | 882.4360, 882.4310 |
| Proprietary names | Bur PM2-70 80K Diam 4 St; Bur PM2-95 80K Mstick 3 St; Bur PM2-125 80K Diam 4 St; AQUACARE; Bur PM2-70 80k Steel 3.1 St; Bur PM2-70 80K Mstick 1.8 St; Bur PM2-150 80k Diam C 5 St; Bur PM2-95 80K Drum 5 x 10 St; Bur PM2-125 80K Diam C 4 St; Bur Cranial Straight 15mm St |
Source: openFDA. Public-domain (CC0).