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EUDAMED last updated this device on May 9, 2022
B-71277HFCONTROL DILUTION SET 80 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by ARKRAY Factory, Inc.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-71277HF71277D-71277HF
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01019001BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
JP-MF-000003008Sterile
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 certificate specifically references this device's Basic UDI-DI.
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.4987486BC0107293H2On the marketConcentrated Washing Solution 3B-79053JFOn the marketConcentrated Washing Solution 34987486BC0107293H2On the marketCONTROL DILUTION SET 804987486BC0107350GMOn the marketCONTROL DILUTION SET 80B-71265H8On the marketCuvette (heparin)4987486BC0108238GZOn the market