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EUDAMED last updated this device on May 17, 2022
574400328READER8MHistareader501 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by RefLab Aps. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05744003280018RLA501(01)05744003280018
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020280LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIESPrimary placement in Denmark; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Jan 1, 2007 | Still on market |
| Germany | Aug 1, 2009 | Still on market |
| Spain | Nov 1, 2011 | Still on market |
DK-MF-000021844The 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.
574400328RINSECHOn the marketDiluent (NaOH), 1 L574400328DILUENTGGOn the marketDiluent (NaOH), 10 mL574400328DILUENTGGOn the marketHistareader501-1574400328READER8MOn the marketIL-3, 0,1 µg5744003280IL34QOn the marketLysis reagent (HClO4 - 7%), 10 mL5744003280LYSIS5NOn 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.