- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Aug 19, 2022
84269500068315PPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →0018262900 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Instrumentation Laboratory SpA. 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 →08426950006831Basic 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 →84269500068315P0018262900UDI 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 →(01)08426950006831
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.
W0201010185CHEMISTRY 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 16 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Aug 19, 2022 | Still on market |
| Austria | Nov 9, 2022 | Still on market |
| Belgium | Nov 9, 2022 | Still on market |
| Cyprus | Nov 9, 2022 | Still on market |
| Germany | Nov 9, 2022 | Still on market |
| EL | Nov 9, 2022 | Still on market |
| Spain | Aug 19, 2022 | Still on market |
| Croatia | Nov 9, 2022 | Still on market |
| Ireland | Aug 19, 2022 | Still on market |
| Liechtenstein | Nov 9, 2022 | Still on market |
| Luxembourg | Aug 19, 2022 | Still on market |
| Malta | Aug 19, 2022 | Still on market |
| Netherlands | Nov 9, 2022 | Still on market |
| Poland | Nov 9, 2022 | Still on market |
| Romania | Nov 9, 2022 | Still on market |
| XI | Aug 19, 2022 | Still on market |
IT-MF-000009277Certificate health across this manufacturer's portfolio.
V12 034483 0002IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →