Establishment registration
BOULE MEDICAL AB
FDA establishment registration 3004008703 · Spanga Stockholm, SE
Key facts
| Registration number | 3004008703 |
|---|---|
| Establishment name | BOULE MEDICAL AB |
| Owner/operator | Boule Diagnostics AB |
| Owner/operator number | 9034165 |
| FEI number | 3004008703 |
| Address | Fagerstagatan 7 |
| City | Spanga Stockholm |
| Country | SE |
| Establishment types | Manufacturer |
| Registration valid through | 2026 |
| Product codes listed | GGK, GIF, GIO, GKZ, JCB |
| Device classes | 1, 2 |
At a glance
- 1–9 Device listings
- 1–9 UDI devices (GUDID)
- Current Registration current
- 1–9 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