Heliocos GmbH
DE-MF-000006272 · Germany · Karlsruhe
Heliocos GmbH is registered in the European database on medical devices as a manufacturer, with 224 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 224 |
|---|
Most frequent device types declared: Abformpfosten, Driver for Handpiece, Driver for ratchet, MUA cover cap, Scanbody.
Catalogue references include 21.710.34.000, 21.848.30.000, 23.008.45.000, 23.009.57.000, 23.061.50.000, 31.020.23.025.
European nomenclature codes declared: Q010207, P01020180, Z12119099, Z12110180.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 224 |
| 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 | 224 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Heliocos GmbH was not found in either the U.S. or the Canadian register.