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, Amedtec ECGpro Holter-RR USB-C, HBPM Cuff, Scanlight by IEM USB-C, Tel-O-Graph GSM Plus.
Among these devices, 4 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- Mobil-O-Graph® Manschette, L
- Mobil-O-Graph® Manschette, M
- Mobil-O-Graph® Manschette, S
- Mobil-O-Graph® Manschette, XL
- Mobil-O-Graph® Manschette, XS
- Tel-O-Graph GSM Plus
- Tel-O-Graph GSM Plus (LTE)
- Tel-O-Graph® Manschette L
- Tel-O-Graph® Manschette M
- Tel-O-Graph® Manschette S
- Tel-O-Graph® Manschette XL
Showing 12 of 17 declared devices.
Catalogue references include 030100001, 030100010, 04041346101026, 04041346101057, 04041346101200, 04041346102122.
European nomenclature codes declared: Z12040180, Z1203020685, Z1203020302, Z12050404.
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 |
Device-level evidence
| Devices with a numeric GTIN | 17 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 58.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IEM GMBH |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2010-11-04 |
Licence types: System (4), Single Device (1).
Licensed under: HYPERTENSION MANAGEMENT SOFTWARE HMS-CS, MOBIL-O-GRAPH 24H PWA - AMBULATORY BLOOD PRESS, AMBULATORY BLOOD PRESSURE MONITOR ABPM 7100, TEL-O-GRAPH BT, USB-CABLE.
North American profile: Both markets. IEM GmbH is registered in both the United States and Canada.