CareDx AB
SE-MF-000040995 · Sweden · Stockholm
CareDx AB is registered in the European database on medical devices as a manufacturer, with 183 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| other | 183 |
|---|
Most frequent device types declared: Olerup SSP, AlloSeq Tx 17, Olerup QTYPE 11, Olerup SSP , QTYPE.
Among these devices, 1 are declared sterile.
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 | CAREDX AB (SE) · FDA 3002522915 |
| Devices in EUDAMED | 183 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 7091956-1 | issued | 2030-09-23 |