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EUDAMED last updated this device on Sep 30, 2024
697304909Model62ULMicrobial Detection System 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 Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697304909621805111，05112，05115，05116，05117，05118，05119CN-MF-000012110(01)06973049096218
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 4 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jan 31, 2024 | Dec 31, 2024 |
| France | Jan 31, 2024 | Dec 31, 2024 |
| Latvia | Jan 31, 2024 | Dec 31, 2024 |
| Poland | Jan 31, 2024 | Dec 31, 2024 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02030201AUTOMATED BLOOD CULTURE ANALYSERSPrimary 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 →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.697304909Model70UKOn the marketAutoMic-i600697304909Model61UJOn the marketIntegrated Target Plate 24697304909M6002A7On the marketMicrobial Turbidimeter697304909Model031FQOn the marketSample Management Module697304909Model027FZOn the market05042697304909Model58UVOn the marketNo certificate specifically references this device's Basic UDI-DI.