FDA Device Establishments · JSON-LD · Markdown
FEI 3017401510 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3017401510 |
|---|---|
| Owner / Operator | CathVision ApS (#10085183) |
| Address | Lygten 37 st. th., Copenhagen NV Hovedstaden, 2400, DK |
| Mandatory US Agent | Graematter, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DQK |
| Regulation § (21 CFR) | 870.1425 |
| Proprietary names | ECGenius System |
Source: openFDA. Public-domain (CC0).