Maquet Critical Care AB
SE-MF-000001264 · Sweden · Solna
Maquet Critical Care AB is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 52 |
|---|---|
| Class IIb | 19 |
Most frequent device types declared: 6891100, PV8810.
Among these devices, 18 are declared sterile, 21 active, 19 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 CRITICAL CARE AB (SE) · FDA 8010042 |
| Devices in EUDAMED | 71 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 072017 0015 | issued | 2030-02-16 |