- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Feb 8, 2022
7613336013209Zcobas e 411 analyzer (rack system) 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.
0401563092472104775279001(01)04015630924721
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)1 warning recorded — scroll inside the panel to see all entries.
JP-MF-000016991The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
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.
761333602948BUOn the marketcobas e 402 analytical unit761333601773BAOn the marketcobas e 411 analyzer (disk system)761333601321A3On the marketcobas e 411 analyzer Instrument Software Version 03-02761333601991BNOn the marketcobas e 411 analyzer Language Pack - Russian Version 3.2.1.ru7613336020049TOn the marketcobas e 411 analyzer Language Pack – Bulgarian Version 3.2.1 bg7613336020049TOn the market