GME German Medical Engineering GmbH
DE-MF-000009384 · Germany · Nürnberg
GME German Medical Engineering GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 8 |
|---|
Most frequent device types declared: 1000, 1040, 1050, 1060, 1070.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- ExSys
- FlexSys
- LinScan
- LinScan 808
- MED-UV EPL 308
- MED-UV EPL 308 lite
- TwinScan
Catalogue references include 1000, 1040, 1050, 1060, 1070, 1091.
European nomenclature codes declared: Z12040202, Z12040201, Z12011019,Z12040202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. GME German Medical Engineering GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1532570-1 | amended | 2030-10-22 |