- Role
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CZ-MF-000033468ED7042 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by EXBIO Praha, a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 24, 2026
B-08594208060123Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08594208060123
16 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 Czechia; available across 21 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Sep 1, 2012 | Still on market |
| Austria | Feb 6, 2024 | Still on market |
| Belgium | May 15, 2023 | Still on market |
| Germany | Jan 28, 2015 | Still on market |
| Estonia | Apr 5, 2022 | Still on market |
| EL | Dec 4, 2013 | Still on market |
| Spain | Apr 9, 2014 | Still on market |
| France | Mar 31, 2014 | Still on market |
| Hungary | Jul 23, 2014 | Still on market |
| Ireland | Feb 6, 2023 | Still on market |
| Italy | Aug 31, 2016 | Still on market |
| Lithuania | Nov 23, 2021 | Still on market |
| Latvia | Mar 2, 2016 | Still on market |
| Netherlands | Mar 10, 2014 | Still on market |
| Poland | Feb 29, 2016 | Still on market |
| Portugal | Mar 7, 2022 | Still on market |
| Romania | Jan 24, 2017 | Still on market |
| Sweden | Dec 14, 2021 | Still on market |
| Slovenia | Jun 15, 2022 | Still on market |
| Slovakia | Jun 28, 2013 | Still on market |
| Türkiye | Jun 4, 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.
08594208060123Basic 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-08594208060123ED7042UDI 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.
W010399HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYSTOLOGY REAGENTS - OTHERCertificate health across this manufacturer's portfolio.
2025-IVDR/QS-002Issued2025-IVDR/QS-002Issued2024-IVDR/QS-004Supplemented2024-IVDR/QS-004SupplementedNotified 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 →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 →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 →No certificate specifically references this device's Basic UDI-DI.