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SE-MF-000002020CE 708525CE 731750Xpert® is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List A. Manufactured by Cepheid AB. 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-07332940007409Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07332940007409
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 17 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Oct 29, 2021 | Still on market |
| Austria | Jun 8, 2021 | Still on market |
| Belgium | Sep 14, 2021 | Still on market |
| Czechia | Mar 27, 2023 | Still on market |
| Germany | May 31, 2021 | Still on market |
| Estonia | Feb 21, 2022 | Still on market |
| EL | Nov 4, 2022 | Still on market |
| Spain | May 31, 2021 | Still on market |
| Finland | Nov 17, 2023 | Still on market |
| France | Jun 1, 2021 | Still on market |
| Ireland | Jun 15, 2022 | Still on market |
| Italy | Sep 23, 2021 | Still on market |
| Lithuania | Jan 10, 2024 | Still on market |
| Latvia | Jul 6, 2023 | Still on market |
| Poland | Oct 20, 2021 | Still on market |
| Portugal | Aug 3, 2022 | Still on market |
| Türkiye | Apr 15, 2024 | 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.
07332940007409Basic 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-07332940007409GXHIV-VL-XC-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.
W0105030107HIV 1 - 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.