FDA Device Establishments · JSON-LD · Markdown
FEI 3010837197 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3010837197 |
|---|---|
| Owner / Operator | Fischer ANalysen Instrumente GmbH (#10062455) |
| Address | Brahestr. 25-27, Leipzig Saxony, 04347, DE |
| Mandatory US Agent | Gulf Coast Scientific, Inc. / ARJ Medical, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OZA |
| Regulation § (21 CFR) | 866.3110 |
| Proprietary names | PyloPlus |
Source: openFDA. Public-domain (CC0).