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
Most frequent device types declared: AlloSeq Tx 17, OLerup SSP, Oelrup SSP, Olerup QTYPE 11, Olerup QTYPE LC480 II Cal Plate.
Among these devices, 1 are declared sterile.
Catalogue references include 101.120-06u, 101.121-04u, 101.231-24u, 101.522-03u, 101.601-12u, 101.603-12u.
European nomenclature codes declared: W01030403, V92.
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 |
Device-level evidence
| Devices with a numeric GTIN | 183 |
|---|---|
| Found in the U.S. device database | 165 |
| Share | 90.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CAREDX AB |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2009-04-09 |
Licence types: Test Kit (1), Device Family (1).
Licensed under: OLERUP SSP HLA TYPING KITS, OLERUP SSP HLA NEGATIVE CONTROL.
North American profile: Both markets. CareDx AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 7091956-1 | issued | 2030-09-23 |