Cepheid AB
SE-MF-000002020 · Sweden · Solna
Cepheid AB is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Xpert®
Showing 12 of 22 declared devices.
Catalogue references include GXCT/NG-CE-120, GXHCV-FS-CE-10, GXHCV-VL-CE-10, GXHIV-QA-XC-CE-10, GXMRSA/SA-SSTI-CE, GXMRSA/SABC-CE-10.
European nomenclature codes declared: W0105070501, W0105011203, W0105010703, W0105020307, W0105030107, W0105011804.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CEPHEID AB (SE) · FDA 3009613136 |
| Devices in EUDAMED | 22 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 22 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CEPHEID |
What it holds in Canada
| Licences on record | 19 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 13 |
| Class 4 devices | 4 |
| First licensed | 2008-01-24 |
Licence types: Test Kit (15), System (3), Device Family (1).
Licensed under: GENEXPERT DX SYSTEM, XPERT GBS ASSAY, XPERT MRSA/SA SSTI, XPERT MRSA/SA BLOOD CULTURE, XPERT FII & FV, XPERT VANA.
North American profile: Both markets. Cepheid AB is registered in both the United States and Canada.