- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Feb 10, 2022
761333601576B6cobas c 503 analytical unit 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.
07613336158784 08463662001(01)07613336158784
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010107CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)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.
761333601997C2On the marketcobas c 311 analyzer Language Pack 1.13.1.tr761333601997C2On the marketcobas c 311 analyzer Language Pack 1.13.1.zh761333601997C2On the marketcobas c 513 analyzer761333601501A7On the marketcobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1761333602156AKOn the marketcobas c 513 analyzer Language Pack -Chinese Version 2.6.zh761333602949BWOn the market