FDA Device Establishments · JSON-LD · Markdown
FEI 3035710892 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3035710892 |
|---|---|
| Owner / Operator | MacroLux Medical Technology Co., Ltd. (#10089857) |
| Address | 501, Building 6, No.4, Xinxi Road, Songshan Lake High-Tech Industrial Development Zone, Dongguan Guangdong, 523787, CN |
| Mandatory US Agent | ICAS Biologics Co., Ltd. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HFB |
| Regulation § (21 CFR) | 884.4530 |
| Proprietary names | Single-Use Biopsy Forceps (BF-S-1.6X380, BF-S-1.6X380-G, BF-S-1.6X380-O); Single-Use Alligator Grasper (GF-S-1.6X380, GF-S-1.6X380-G, GF-S-1.6X380-O) |
Source: openFDA. Public-domain (CC0).