- Organization name
- UDI-DI code
- Reference / catalog number
US-MF-000010979Xpert® is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Cepheid. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 2, 2026
B-07332940006297Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07332940006297
7 warnings recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Netherlands; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Oct 6, 2017 | Still on market |
| Austria | Feb 16, 2018 | Still on market |
| Belgium | Dec 4, 2017 | Still on market |
| Czechia | Dec 15, 2017 | Still on market |
| Germany | Jan 22, 2019 | Still on market |
| Denmark | Jun 10, 2021 | Still on market |
| Estonia | Feb 5, 2020 | Still on market |
| EL | Jan 22, 2019 | Still on market |
| Spain | Mar 14, 2018 | Still on market |
| Finland | Jan 17, 2018 | Still on market |
| France | Nov 29, 2017 | Still on market |
| Ireland | Jan 3, 2023 | Still on market |
| Italy | Oct 16, 2017 | Still on market |
| Poland | Apr 24, 2020 | Still on market |
| Portugal | Aug 11, 2020 | Still on market |
| Sweden | Mar 5, 2020 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07332940006297Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-07332940006297XPRSTREPA-CE-10UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105011103STREP. A DETECTION BY NA REAGENTSNo certificate specifically references this device's Basic UDI-DI.
No 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.