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EUDAMED last updated this device on Oct 1, 2024
50552732AREASGN020F8SIGNAL REAGENT – EV701 (REAG SGNL – EV701) 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.
05055273202694EV3601(01)05055273202694
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.
Only one batch of Signal Reagent - EV701 should be used on the analyser at any one time and recalibration is required with change in each lot.
XI-MF-000028410The 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.
No 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.50552732ASERDIL048KTOn the marketSERUM INDICES (SERUM INDICES)50552732BSEMDCE128EFOn the marketSERUM LOW/HIGH CALIBRATORS (ISE CAL S)50552732BSLHCAL174GLOn the marketSIGNAL REAGENT – EV840 (REAG SGNL – EV840)50552732AREASGN020F8On the marketSIGNAL REAGENT – EV841 (REAG SGNL – EV841)50552732AREASGN020F8On the marketSIGNAL REAGENTS – EV805 (REAG SGNL – EV805)50552732AREASGN020F8On the market