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EUDAMED last updated this device on Apr 26, 2023
B-07332940000134Xpert® is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Cepheid AB. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07332940000134B-07332940000134GXMRSA/SA-BC-CE-10(01)07332940000134
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104080601NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP7 warnings recorded — scroll inside the panel to see all entries.
CW010CW267CW009CW007CW416CW422CW175No certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 19 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Feb 1, 2015 | Still on market |
| Austria | Mar 1, 2015 | Still on market |
| Belgium | Jun 1, 2015 | Still on market |
| Bulgaria | Jan 1, 2019 | Still on market |
| Czechia | Jun 1, 2015 | Still on market |
| Germany | Mar 1, 2015 | Still on market |
| EL | Nov 1, 2015 | Still on market |
| Spain | Mar 1, 2015 | Still on market |
| Finland | Feb 1, 2015 | Still on market |
| France | Mar 1, 2015 | Still on market |
| Ireland | Aug 1, 2015 | Still on market |
| Italy | Mar 1, 2015 | Still on market |
| Lithuania | Aug 1, 2015 | Still on market |
| Latvia | Mar 1, 2019 | Still on market |
| Norway | Sep 1, 2018 | Still on market |
| Poland | Jul 1, 2020 | Still on market |
| Portugal | Jun 1, 2019 | Still on market |
| Sweden | Mar 1, 2015 | Still on market |
| XI | May 23, 2022 | Still on market |
SE-MF-000002020No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.