FDA Device Establishments · JSON-LD · Markdown
FEI 3006783791 · Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3006783791 |
|---|---|
| Owner / Operator | GaleMed Corporation (#8043316) |
| Address | Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road, 361026 Fujian Province, China, XIAMEN Fujian, 361026, CN |
| Mandatory US Agent | ProMedic, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KGB |
| Regulation § (21 CFR) | 868.5570 |
| Proprietary names | OM-2 HiO2 Mask, Child w/Tubing, PVC Bag; OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag; OM-2 HiO2 Mask, Child w/Tubing |
Source: openFDA. Public-domain (CC0).