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EUDAMED last updated this device on Oct 20, 2022
761333601562ATcobas e 801 MSB/MSBL 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.
0761333615856208459606 001(01)07613336158562
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020103AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
JP-MF-000016991The 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.
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.
7613336020049TOn the marketcobas e 411 analyzer Language Pack – Turkish Version 3.2.1.tr7613336020049TOn the marketcobas e 801 analytical unit761333601561AROn the marketcobas pro A-Gate Upgrade Kit761333602670B6On the marketcobas pro B-Gate update kit761333601609AUOn the marketcobas pro B-Gate Upgrade Kit761333601780B7On the marketCertificate 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 →