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EUDAMED last updated this device on Oct 1, 2024
50552732AREASGN020F8SIGNAL REAGENTS – EV805 (REAG SGNL – EV805) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Randox Laboratories Limited. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05055273202335EV3529(01)05055273202335
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES1 warning recorded — scroll inside the panel to see all entries.
CW010XI-MF-000028410No 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.The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in XI; available across 1 country total.
Placed on the market in XI; per-country availability dates not published.
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.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
50552732AREASGN020F8On the marketSIGNAL REAGENT – EV840 (REAG SGNL – EV840)50552732AREASGN020F8On the marketSIGNAL REAGENT – EV841 (REAG SGNL – EV841)50552732AREASGN020F8On the marketsLDL CALIBRATOR (sLDL CAL)50552732BSLDLCR100K8On the marketsLDL CONTROL LEVEL 1 (sLDL CONTROL 1)50552732BSLDLCL099K6On the marketsLDL CONTROL LEVEL 2 (sLDL CONTROL 2)50552732BSLDLCL099K6On the market