Humanelektronik GmbH
DE-MF-000013990 · Germany · Worms
Humanelektronik GmbH is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 37 |
|---|
Most frequent device types declared: Augensteuerung SeeTech, HE Kommunikator, HE Kommunikator Basic X, HE Kommunikator PROEye, HE Kommunikator light II.
Among these devices, 37 are declared active.
Devices declared under this manufacturer
- Augensteuerung SeeTech Mobil Key
- Augensteuerung SeeTech Only
- Augensteuerung SeeTech Pro II Symbol 15\
- Basic X10 GoTalkNow
- Basic X12 GoTalkNow
- Basic X8 Assistive Express
- Basic X8 GoTalkNow
- HE Kommunikator light II AssistiveExpress
- HE Kommunikator light II GoTalkNow
- HE Kommunikator light II Mini MetaTalk SE
- HE Kommunikator light II Pro AssistiveExpress
- HE Kommunikator light II Pro GoTalkNow
Showing 12 of 37 declared devices.
Catalogue references include 10021044, 100222204, 100222208, 100222223, 100222224, 1444.
European nomenclature codes declared: Y214209, Y214299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 37 |
| 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 | 37 |
|---|---|
| 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. Humanelektronik GmbH was not found in either the U.S. or the Canadian register.