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EUDAMED last updated this device on Nov 9, 2023
805360894CML07013-14F8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Reagent bottle 15ml for 30 positions tray is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Edif Instruments S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →80536089409664Basic 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 →805360894CML07013-14F8CML07013A-001AUDI 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 →(01)80536089409664
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLESW0201010185CHEMISTRY ANALYSERS - CONSUMABLESSterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
IT-MF-000009556No 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.805360894ES000044ZOn the marketQCA Bio 200 (669400)805360894ES000024VOn the marketReaction Cells starter kit (20 Pcs) V shape + extraction tool ACC07017A-001A805360894CML07011GCOn the marketReagent bottle 25ml for 27 positions tray805360894CML00710-00711WFOn the marketReagent bottle 35ml for 30 positions tray805360894CML07013-14F8On the marketReagent Bottle 50ml for 30 positions tray805360894CML07026-27GHOn the market