FDA Device Establishments · JSON-LD · Markdown
FEI 3008215723 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3008215723 |
|---|---|
| Owner / Operator | L Z Form Kft (#10043808) |
| Address | Ipari Park Nyugat hrsz. 5704/4, Ajka Veszprem, 8400, HU |
| Mandatory US Agent | Pragmatic Compliance dba FDAbasics |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HRX |
| Regulation § (21 CFR) | 888.1100 |
| Proprietary names | Arcadia Balloon Catheter |
Source: openFDA. Public-domain (CC0).