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ES-MF-000002193CerTest Entamoeba 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 Jul 7, 2026
84354402IDXGASTROB_EH6JPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08435440206415
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.
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 Spain; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
| Slovakia | — | 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.
08435440206415Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
84354402IDXGASTROB_EH6JEH820001VCUDI 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.
W0105090499PARASITES - RT & POC - OTHERNo 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.No certificate specifically references this device's Basic UDI-DI.
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