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EUDAMED last updated this device on Sep 7, 2022
761333602635B4cobas pure integrated solutions Language Pack - Spanish Version 1.3.1.es is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Hitachi High-Tech Corporation. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
JP-MF-000016991(01)07613336218556
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 Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07613336218556Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
761333602635B409756841001UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010182CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIESW0201020182AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
MDR 840787IssuedNotified 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 →761333602146AGOn the marketcobas pure integrated solutions Language Pack - Simplified Chinese Version 01-02761333602146AGOn the marketcobas pure integrated solutions Language Pack - Spanish Version 01-02761333602146AGOn the marketcobas pure integrated solutions Language Pack – Chinese Version 1.3.zh761333602635B4On the marketcobas pure integrated solutions Language Pack – Czech Version 1.3.cs761333602635B4On the marketcobas pure integrated solutions Language Pack – English Version 1.3.en761333602635B4On the marketNo certificate specifically references this device's Basic UDI-DI.