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EUDAMED last updated this device on Dec 21, 2022
805360894ACC053186NRemovable sample tray 30+30 positions, 12mm tubes - for samples barcode reader 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.
IT-MF-000009556(01)80536089406212
The 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.
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.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
80536089406212Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
805360894ACC053186NACC05318D-001AUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010180CHEMISTRY ANALYSERS - HARDWARE ACCESSORIESW0201020180AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →805360894ACC05601-02-0377On the marketReagent screw cap tube 10.8 x 44 mm 2mL805360894CML10014FCOn the marketRemovable sample tray 20+20 positions with tubes clips, 12/16mm tubes+ cups805360894ACC053186NOn the marketRemovable sample tray805360894ACC053186NOn the marketRemovable sample tray (30+30 positions of 12-12.5x75mm, 1 ml cups w/ adapter) for barcoded primary tubes805360894ACC053186NOn the marketRemovable sample tray 30+20 positions (30 12mm/55H tubes, 20 cups)805360894ACC053186NOn 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.No certificate specifically references this device's Basic UDI-DI.