- Role
- Country
- Date of registration
- Address
DK-MF-000036335No 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.2cx-CRCSTA is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by 2cureX A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 31, 2024
2321183242cxCRCSTAGNPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
29418000002cxSTA
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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 Denmark; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | May 31, 2024 | Jan 2, 2090 |
| Austria | May 31, 2024 | Jan 2, 2090 |
| Belgium | May 31, 2024 | Jan 2, 2090 |
| Bulgaria | May 31, 2024 | Jan 2, 2090 |
| Cyprus | May 31, 2024 | Jan 2, 2090 |
| Czechia | May 31, 2024 | Jan 2, 2090 |
| Germany | May 31, 2024 | Jan 2, 2090 |
| Estonia | May 31, 2024 | Jan 2, 2090 |
| EL | May 31, 2024 | Jan 2, 2090 |
| Spain | May 31, 2024 | Jan 2, 2090 |
| Finland | May 31, 2024 | Jan 2, 2090 |
| France | May 31, 2024 | Jan 2, 2090 |
| Croatia | May 31, 2024 | Jan 2, 2090 |
| Hungary | May 31, 2024 | Jan 2, 2090 |
| Ireland | May 31, 2024 | Jan 2, 2090 |
| Iceland | May 31, 2024 | Jan 2, 2090 |
| Italy | May 31, 2024 | Jan 2, 2090 |
| Liechtenstein | May 31, 2024 | Jan 2, 2090 |
| Lithuania | May 31, 2024 | Jan 2, 2090 |
| Luxembourg | May 31, 2024 | Jan 2, 2090 |
| Latvia | May 31, 2024 | Jan 2, 2090 |
| Malta | May 31, 2024 | Jan 2, 2090 |
| Netherlands | May 31, 2024 | Jan 2, 2090 |
| Norway | May 31, 2024 | Jan 2, 2090 |
| Poland | May 31, 2024 | Jan 2, 2090 |
| Portugal | May 31, 2024 | Jan 2, 2090 |
| Romania | May 31, 2024 | Jan 2, 2090 |
| Sweden | May 31, 2024 | Jan 2, 2090 |
| Slovenia | May 31, 2024 | Jan 2, 2090 |
| Slovakia | May 31, 2024 | Jan 2, 2090 |
| Türkiye | May 31, 2024 | Jan 2, 2090 |
| XI | May 31, 2024 | Jan 2, 2090 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
29418000002cxSTABasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
2321183242cxCRCSTAGN2cx-CRCSTAUDI 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.
W02050285MICRO-ARRAY INSTRUMENTS - CONSUMABLESNo certificate specifically references this device's Basic UDI-DI.