DH Healthcare GmbH
DE-MF-000009069 · Germany · Bonn
DH Healthcare GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: DeepUnity PACSonWEB, DeepUnity Viewer, DxCare Prescriptions Multimodales, ORBIS Anesthesia, ORBIS Clinical Support.
Among these devices, 17 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- DeepUnity Diagnost
- DeepUnity PACSonWEB
- DeepUnity Viewer
- DxCare Prescriptions Multimodales
- ORBIS Anesthesia
- ORBIS Clinical Support
- ORBIS ICU-Manager
- ORBIS Medication
- amPHI
- clinalytix
- clinalytix Medical AI
- clinalytix Rules
Showing 12 of 17 declared devices.
Catalogue references include ORBIS Anesthesia, ORBIS ICU-Manager, ORBIS Medication, amPHI, clinalytix, clinalytix Medical A.
European nomenclature codes declared: Z120499, V92, Z110603.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| 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 | 17 |
|---|---|
| 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. DH Healthcare GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620120401 | issued | 2027-03-13 |