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EUDAMED last updated this device on Aug 30, 2023
376017308KMSMPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →KENZA MAX BioChemisTry PHOTOMETER is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by BIOLABO. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →03760173087006Basic 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 →376017308KMSMKENZA MAXUDI 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 →(01)03760173087006
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.
W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
FR-MF-000001633No 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.376017308K2QZOn the marketKENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories376017308K4R5On the marketKENZA 450TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories376017308K4R5On the marketKENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories376017308K1QXOn the marketNaOH Solution 0.4 N376017308NAOHB6On the marketOWREN KOLLER BUFFER376017308OWKK7On the market