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EUDAMED last updated this device on Aug 29, 2023
B-780609999TRBM Test HbA1c Control is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by JEOL Ltd. MF. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-780609999TR780609999D-780609999TR
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010214GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Netherlands; available across 1 country total.
Placed on the market in Netherlands; per-country availability dates not published.
JP-MF-000026608Sterile
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.
4987762B04900KKOn the marketBM Test Cuvette Conditioner4987762B04900KKOn the marketBM Test HbA1c CalibratorB-780609981T6On the marketBM Test HbA1c DiluentB-780610008PTOn the marketBM Test HbA1c Reagent 1B-780609956T7On the marketBM Test HbA1c Reagent 2B-780609972T5On the marketNo 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.