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EUDAMED last updated this device on Aug 16, 2025
456018921000006073AIA-PACK DETECTOR STANDARDIZATION TEST CUP is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Tosoh Corporation. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
145601892109880020970(01)14560189210988
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLESJP-MF-000024143The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Belgium; available across 1 country total.
Placed on the market in Belgium; per-country availability dates not published.
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 →45601892100040027HOn the marketAIA-900 19tray Sorter45601892100040017FOn the marketAIA-900 9tray Sorter45601892100040017FOn the marketAIA-PACK SAMPLE TREATMENT CUP456018921000006175On the marketAIA-PACK SUBSTRATE SET II456018921000006277On the marketAuto-Prep Unit for AIA-CL120045601892100040047MOn the marketCertificate health across this manufacturer's portfolio.
HX 2048822-1SupplementedNotified 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 →No certificate specifically references this device's Basic UDI-DI.