eResearchTechnology GmbH
DE-MF-000008015 · Germany · Estenfeld
eResearchTechnology GmbH is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 39 |
|---|
Most frequent device types declared: AM3.
Among these devices, 39 are declared active.
Devices declared under this manufacturer
- CardioSphere
- ERT PT
- MasterScope
- MasterScope CT
- MasterScope ECG
- MasterScope WSSU
- MasterScope WSSU / MasterScope ECG
- Pneumotach
- Rotationsflowgeber
- SpiroSphere
- SpiroSphere ECG
- SpiroSphere Sensor
Showing 12 of 39 declared devices.
Catalogue references include 151222, 151261, 151313, 171600, 706000, 706235.
European nomenclature codes declared: Z12150101, C020599,Z12150101, C020599, Z12150102, Z12159082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | eResearchTechnology GmbH (DE) · FDA 3008505660 |
| Devices in EUDAMED | 39 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 39 |
|---|---|
| Found in the U.S. device database | 37 |
| Share | 94.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ERESEARCH TECHNOLOGY GMBH |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2002-04-04 |
Licence types: System (4), Single Device (2), Device Family (1).
Licensed under: ASTHMA MONITOR, MASTERSCOPE, MASTERSCOPE ECG, SPIROSPHERE, MASTERSCOPE WSSU, SPIROSPHERE ECG.
North American profile: Both markets. eResearchTechnology GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 084128 0024 | issued | 2027-07-31 |