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EUDAMED last updated this device on Oct 20, 2022
761333601371AJcobas 8000 c 701 Module 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.
0401563092825505641489001(01)04015630928255
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010108CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)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 →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.
No certificate specifically references this device's Basic UDI-DI.
761333601519ASOn the marketcobas 8000 Additional ISE KIT761333601422AAOn the marketcobas 8000 B-Gate KIT761333601413A9On the marketcobas 8000 c 702 Module761333601421A8On the marketcobas 8000 Connection Unit761333603370AWOn the marketcobas 8000 Core Unit761333601370AGOn the market