- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 25, 2022
843528739705JGJUNO Automatic eCLIA Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Linear Chemicals S.L.U. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
843528739705577000108435287397055
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)2 warnings recorded — scroll inside the panel to see all entries.
Biohazard. Alerts the operator to operate according to the steps indicated by this symbol, otherwise there may be potential hazard of biological infection.
Prevention of electric shock/Warning. Alerts the operator to operate according to the steps indicated by this symbol, otherwise serious injury may be caused.
ES-MF-000003284Primary placement in Spain; available across 1 country total.
Placed on the market in Spain; 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 →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.
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