Barkey GmbH & Co. KG
DE-MF-000005854 · Germany · Griesheim
Barkey GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 159 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 159 |
|---|
Among these devices, 159 are declared active.
Catalogue references include 00000466, 00000476, 00000477, 00003284, 00003287, 00011166.
European nomenclature codes declared: Z12019009, Z12019008, Z12019099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 159 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 159 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 2.5 % |
⚠ 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 listing | Licensed in Canada |
|---|---|
| Matched entry | BARKEY GMBH & CO. KG |
North American profile: Canada only. Barkey GmbH & Co. KG holds a Canadian licence but was not found in the U.S. register.