EU → North America Device Access

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 IIa176

Most frequent device types declared: B-81, Cutanous electrodes, DD45, EARturtle, Ear tips (Elastosil).

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Showing 12 of 176 declared devices.

Catalogue references include 8012977, 8012993, 8013006, 8049700, 8100825, 8102682.

European nomenclature codes declared: Z12149085, Z12140380, Z12140385, Z12149080.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED176
Country of registrationDenmark

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN176
Found in the U.S. device database171
Share97.2 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryDGS DIAGNOSTICS A/S

What it holds in Canada

Licences on record7
Currently active0
Class 2 devices7
First licensed2022-01-18

Licence types: Device Family (7).

Licensed under: BONE CONDUCTOR HEADSETS RADIOEAR, HEADSETS RADIOEAR, INSERT EARPHONES RADIOEAR, AUDIOMETRIC HEADSETS RADIOEAR, GOLD EARTIP ELECTRODE, ELECTRODE.

North American profile: Canada only. DGS Diagnostics A/S holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

CertificateStatusExpiry
G10 092577 0008issued2027-04-25

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