DGS Diagnostics A/S
DK-MF-000020570 · Denmark · Middelfart
DGS Diagnostics A/S is registered in the European database on medical devices as a manufacturer, with 176 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 176 |
|---|
Most frequent device types declared: Ear tips (Elastosil), Ear tips (Foam), Electrode cables, REM Probe tubes, Infant EarCup w/ electrodes.
Among these devices, 7 are declared active.
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 | 176 |
| 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 |
|---|---|---|
G10 092577 0008 | issued | 2027-04-25 |