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ES-MF-000002193VIASURE Entamoeba dispar Real Time PCR Detection Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by CERTEST BIOTEC S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Aug 19, 2026
84354402_MDXGASTROB_ETDR6Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08435440203421
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning 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 Spain; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
08435440203421Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
84354402_MDXGASTROB_ETDR6VS-ETD112LUDI 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.
W0105050399OTHER PARASITOLOGY - NA REAGENTSCertificate health across this manufacturer's portfolio.
HX 1973122-1SupplementedNotified 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 →84354402_MDXIMMUN_EBV64On the marketVIASURE EBV q Real Time PCR Detection Kit84354402_MDXIMMUN_EBV64On the marketVIASURE Entamoeba dispar Real Time PCR Detection Kit84354402_MDXGASTROB_ETDR6On the marketVIASURE Entamoeba dispar Real Time PCR Detection Kit84354402_MDXGASTROB_ETDR6On the marketVIASURE Entamoeba dispar Real Time PCR Detection Kit84354402_MDXGASTROB_ETDR6On the marketVIASURE Entamoeba dispar Real Time PCR Detection Kit84354402_MDXGASTROB_ETDR6On the marketNo certificate specifically references this device's Basic UDI-DI.