MedicalCommunications GmbH
DE-MF-000007645 · Germany · Heidelberg
MedicalCommunications GmbH is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 8 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: Ashvins variant Ashvins Diagnostic Workstation, Ashvins variant HEYEX 2 / HEYEX PACS.
Among these devices, 7 are declared active, 7 with a measuring function.
Devices declared under this manufacturer
- Ashvins
- Ashvins variant Ashvins Diagnostic Workstation
- Ashvins variant HEYEX 2 / HEYEX PACS
Catalogue references include 2.6.0 (Build 2088), 2020 (Build 1891), 2021 (Build1920), 2023 (Build 2088), 2023 (Build 2167), Version 2.5 (1786).
European nomenclature codes declared: Z110603.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 9 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDICALCOMMUNICATIONS GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-03-12 |
Licence types: Device Family (1).
Licensed under: ASHVINS.
North American profile: Canada only. MedicalCommunications GmbH holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 033228 0032 Rev. 00 | issued | 2031-06-09 |
G10 033228 0030 | issued | 2026-06-09 |