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EUDAMED last updated this device on Jun 26, 2026
697304909Model032FSAutoBC 450s is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Autobio Labtec Instruments Co.,Ltd.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697304909431305132(01)06973049094313
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02030201AUTOMATED BLOOD CULTURE ANALYSERSCN-MF-000012110The 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.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
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 →697304909Model032FSOn the marketAutoBC 450 Series-Slave697304909Model032FSOn the marketAutoBC 450s697304909Model032FSOn the marketAutomated Microbial Detection System697304909Model032FSOn the marketIntegrated Target Plate 24697304909M6002A7On the marketMicrobial Turbidimeter697304909Model031FQOn the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.