IEM GmbH
DE-MF-000005735 · Germany · Aachen
IEM GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: ABPM cuff, HBPM Cuff, Tel-O-Graph GSM Plus, Scanlight by IEM USB-C, Amedtec ECGpro Holter-RR USB-C.
Among these devices, 4 are declared active, 4 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 | IEM GMBH (DE) · FDA 9617476 |
| Devices in EUDAMED | 17 |
| Country of registration | Germany |