- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 30, 2022
7613336020049Tcobas e 411 analyzer Language Pack – Czech Version 3.2.1 cs 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.
0761333618126309309489001JP-MF-000016991(01)07613336181263
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020182AUTOMATED 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 →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 – Chinese Version 3.2.1.zh_W107613336020049TOn the marketcobas e 411 analyzer Language Pack – Chinese Version 3.2.1.zh_WXP7613336020049TOn the marketcobas e 411 analyzer Language Pack – Danish Version 3.2.1 da7613336020049TOn the marketcobas e 411 analyzer Language Pack – English version 3.2.1.en7613336020049TOn the marketcobas e 411 analyzer Language Pack – English Version 3.2.2.en7613336020049TOn 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 →