FDA Device Establishments · JSON-LD · Markdown
FEI 3008496528 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3008496528 |
|---|---|
| Owner / Operator | BIOPTIMAL INTERNATIONAL PTE LTD (#9004883) |
| Address | No. 288-13 Shanhai Road, Torch Hi-tech Science Park, Weihai Shandong, 264209, CN |
| Mandatory US Agent | BIOMEDICAL SALES INTERNATIONAL, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DQO, DYG |
| Regulation § (21 CFR) | 870.1200, 870.1240 |
| Proprietary names | Bioptimal Pulmonary Artery Monitoring Catheter |
Source: openFDA. Public-domain (CC0).