BGI EUROPE A/S
DK-MF-000014089 · Denmark · Herlev
BGI EUROPE A/S is registered in the European database on medical devices as a manufacturer, with 140 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 140 |
|---|
Most frequent device types declared: 50 tests/kit, 5 tests/kit, 25 tests/kit, 10 tests/kit, 96 tests.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 140 |
| Country of registration | Denmark |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V13 125836 0004 | issued | 2031-06-28 |