FDA Device Establishments · JSON-LD · Markdown
FEI 3009503584 · Repack or Relabel Medical Device · Status: Active
| FEI Number | 3009503584 |
|---|---|
| Owner / Operator | HCL America, Inc. (#10084715) |
| Address | 248 Armstrong Rd, Pittston, PA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | DRG, MWI, IKN, LEL |
| Regulation § (21 CFR) | 870.2910, 870.2300, 890.1375, 882.5050 |
| Proprietary names | BioStamp NPoint |
Source: openFDA. Public-domain (CC0).