GETEMED Medizin- und Informationstechnik AG
DE-MF-000012384 · Germany · Teltow
GETEMED Medizin- und Informationstechnik AG is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 82 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: ECG-Cable, VitaGuard VG 5, Download Cable, HeartX Recorder ECG Patch, ReSTA.
Among these devices, 20 are declared active, 15 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG (DE) · FDA 3004006614 |
| Devices in EUDAMED | 88 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1624046-1 | supplemented | 2025-10-09 |
HZ 1624046-1 | reissued | 2030-10-09 |