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EUDAMED last updated this device on Sep 29, 2023
8058945151N3100W251N3100 W10 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by ABD SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
480589451503288058945151N3100W251N3100 W10(01)48058945150328
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.
W01020205IMMUNOGLOBULIN E - SCREEN3 warnings recorded — scroll inside the panel to see all entries.
CW010CW007CW032No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market | |
| Romania | Still on market |
IT-MF-000029729No 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.