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EUDAMED last updated this device on Nov 14, 2025
5905817273LAB404PMikroskop Biologiczny OPTA-TECH serii LAB40 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by OPTA-TECH Sp. z o.o.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05905817273027LAB 40(01)05905817273027
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0202050303OPTICAL LABORATORY MICROSCOPESPL-MF-000050182The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; 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 →No certificate specifically references this device's Basic UDI-DI.
5905817273MB2002JOn the marketMB200 S5905817273MB2002JOn the marketMikroskop Biologiczny OPTA-TECH serii LAB 505905817273LAB504SOn the marketMikroskop Biologiczny OPTA-TECH serii MB-55905817273MB5CNOn the marketMikroskop Odwrócony OPTA-TECH serii MW 505905817273MW509COn the marketMikroskop Stereoskopowy OPTA-TECH serii SK5905817273SKL3On the marketNo 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.