- Role
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SE-MF-000010044NIOX VERO is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by NIOX AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 23, 2026
B-07350047030205Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07350047030205
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CW010Sterile
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 Sweden; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | May 21, 2015 | Jun 23, 2036 |
| Austria | May 21, 2015 | Jun 23, 2036 |
| Belgium | May 21, 2015 | Jun 23, 2036 |
| Bulgaria | May 21, 2015 | Jun 23, 2036 |
| Cyprus | May 21, 2015 | Jun 23, 2036 |
| Czechia | May 21, 2015 | Jun 23, 2036 |
| Germany | May 21, 2015 | Jun 23, 2036 |
| Denmark | May 21, 2015 | Jun 23, 2036 |
| Estonia | May 21, 2015 | Jun 23, 2036 |
| EL | May 21, 2015 | Jun 23, 2036 |
| Spain | May 21, 2015 | Jun 23, 2036 |
| Finland | May 21, 2015 | Jun 23, 2036 |
| France | May 21, 2015 | Jun 23, 2036 |
| Croatia | May 21, 2015 | Jun 23, 2036 |
| Hungary | May 21, 2015 | Jun 23, 2036 |
| Ireland | May 21, 2015 | Jun 23, 2036 |
| Iceland | May 21, 2015 | Jun 23, 2036 |
| Italy | May 21, 2015 | Jun 23, 2036 |
| Liechtenstein | May 21, 2015 | Jun 23, 2036 |
| Lithuania | May 21, 2015 | Jun 23, 2036 |
| Luxembourg | May 21, 2015 | Jun 23, 2036 |
| Latvia | May 21, 2015 | Jun 23, 2036 |
| Malta | May 21, 2015 | Jun 23, 2036 |
| Netherlands | May 21, 2015 | Jun 23, 2036 |
| Norway | May 21, 2015 | Jun 23, 2036 |
| Poland | May 21, 2015 | Jun 23, 2036 |
| Portugal | May 21, 2015 | Jun 23, 2036 |
| Romania | May 21, 2015 | Jun 23, 2036 |
| Slovenia | May 21, 2015 | Jun 23, 2036 |
| Slovakia | May 21, 2015 | Jun 23, 2036 |
| Türkiye | May 21, 2015 | Jun 23, 2036 |
| XI | May 21, 2015 | Jun 23, 2036 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07350047030205Basic 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-0735004703020512-1100UDI 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.
W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
IX 1379539-1IssuedHX 1379539-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →