Maquet Cardiopulmonary GmbH
DE-MF-000020091 · Germany · Rastatt
Maquet Cardiopulmonary GmbH is registered in the European database on medical devices as a manufacturer, with 94 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 42 |
|---|---|
| Class I | 26 |
| Class IIb | 26 |
Most frequent device types declared: BE-PAL 1923, PIK 150, BE-PAS 2115, 10020-CE, BE-MECC 50310.
Among these devices, 60 are declared sterile, 25 active, 6 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 | MAQUET CARDIOPULMONARY GmbH (DE) · FDA 8010762 |
| Devices in EUDAMED | 94 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 067154 0016 | issued | 2028-07-25 |