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US-MF-000010979GeneXpert is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. 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 Aug 22, 2022
081164701-GX-X5Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07332940007683
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 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 31 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | May 25, 2022 | Still on market |
| Austria | May 25, 2022 | Still on market |
| Belgium | May 25, 2022 | Still on market |
| Bulgaria | May 25, 2022 | Still on market |
| Cyprus | May 25, 2022 | Still on market |
| Czechia | May 25, 2022 | Still on market |
| Germany | May 25, 2022 | Still on market |
| Denmark | May 25, 2022 | Still on market |
| Estonia | May 25, 2022 | Still on market |
| EL | May 25, 2022 | Still on market |
| Spain | May 25, 2022 | Still on market |
| Finland | May 25, 2022 | Still on market |
| France | May 25, 2022 | Still on market |
| Croatia | May 25, 2022 | Still on market |
| Hungary | May 25, 2022 | Still on market |
| Ireland | May 25, 2022 | Still on market |
| Iceland | May 25, 2022 | Still on market |
| Italy | May 25, 2022 | Still on market |
| Liechtenstein | May 25, 2022 | Still on market |
| Lithuania | May 25, 2022 | Still on market |
| Luxembourg | May 25, 2022 | Still on market |
| Latvia | May 25, 2022 | Still on market |
| Malta | May 25, 2022 | Still on market |
| Norway | May 25, 2022 | Still on market |
| Poland | May 25, 2022 | Still on market |
| Portugal | May 25, 2022 | Still on market |
| Romania | May 25, 2022 | Still on market |
| Sweden | May 25, 2022 | Still on market |
| Slovenia | May 25, 2022 | Still on market |
| Slovakia | May 25, 2022 | Still on market |
| XI | May 25, 2022 | 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.
07332940007683Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081164701-GX-X5GeneXpert II (GX-II)UDI 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.
W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMSNo 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.