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EUDAMED last updated this device on Jan 19, 2026
761333603408AWcobas 8100 automated workflow series Language Pack - Romanian Version 4.11.ro 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)07613336243404
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.
07613336243404Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
761333603408AW10716339001UDI 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.
W02069082VARIOUS SAMPLE PROCESSING INSTRUMENTS - 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 →761333602797BXOn the marketcobas 8100 automated workflow series Language Pack - Portuguese Version 4.8.pt761333602930B9On the marketcobas 8100 automated workflow series Language Pack - Romanian Version 4.10.ro761333603362AXOn the marketcobas 8100 automated workflow series Language Pack - Romanian Version 4.8.ro761333602930B9On the marketcobas 8100 automated workflow series Language Pack - Spanish Version 4.10.es761333603362AXOn the marketcobas 8100 automated workflow series Language Pack - Spanish Version 4.11.es761333603408AWOn the marketNo certificate specifically references this device's Basic UDI-DI.
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.
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