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EUDAMED last updated this device on Oct 2, 2024
50552732AISECLN044EUI.S.E. CLEANER (ISE CLN) 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.
05055273214352RX4047(01)05055273214352
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010185CHEMISTRY ANALYSERS - CONSUMABLES1 warning recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents. ISE Cleaner contains Sodium Azide. Avoid ingestion or contact with skin or mucous membranes. In case of skin contact, flush affected area with copious amounts of water. In case of contact with eyes or if ingested, seek immediate medical attention. Sodium Azide reacts with lead and copper plumbing, to form potentially explosive azides. When disposing of such reagents flush with large volumes of water to prevent azide build up. Exposed metal surfaces should be cleaned with 10% sodium hydroxide.
Primary placement in XI; available across 1 country total.
Placed on the market in XI; per-country availability dates not published.
XI-MF-000028410The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
50552732AHSSCKT056NROn the marketHUMAN PRECISION CONTROL - LEVEL 2 (HUM PREC CONTROL 2)50552732BHUPNCN127PLOn the marketHUMAN PRECISION CONTROL - LEVEL 3 (HUM PREC CONTROL 3)50552732BHUPNCN127PLOn the marketI.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH)50552732AISESOL006MPOn the marketI.S.E. Diluent (ISE DIL)50552732AISEDIL011DBOn the marketI.S.E. DILUENT (ISE DIL)50552732AISEDIL011DBOn the marketNo 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.