Establishment registration
FORTUNA HELIX
FDA establishment registration 3038181305 · Seoul, KR
Key facts
| Registration number | 3038181305 |
|---|---|
| Establishment name | FORTUNA HELIX |
| Owner/operator | Fortuna Helix |
| Owner/operator number | 10093089 |
| FEI number | 3038181305 |
| Address | Seoul Biohub Global Center, Suite 502, 117-3 Hoegi-ro, Dongdaemun-gu |
| City | Seoul |
| Country | KR |
| Establishment types | Manufacturer |
| Registration valid through | 2026 |
| Product codes listed | PTA |
| Device classes | 2 |
At a glance
- 1–9 Device listings
- None UDI devices (GUDID)
- Current Registration current
- None FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database