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EUDAMED last updated this device on Nov 1, 2024
697233785HemaA0024YHematology Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by B&E BIO-TECHNOLOGY CO., LTD.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697233785003780100 80120 80300 80310 80320 80330 80340 8035080200 80500 80301 80400 80600 80900 80910 80920 80930 80360 80370 80380 (01)06972337850037
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0202010201AUTOMATED 3 PART HEMATOLOGY ANALYSERSW0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)1 warning recorded — scroll inside the panel to see all entries.
CN-MF-000023256The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary 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 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.697233785GHgbLyse009BZOn the marketGlycated Hemoglobin AnalyzerB-06972337852369On the marketGlycated Hemoglobin AnalyzerB-06972337851591On the marketMulti Biosensor Module697233785MBM008HXOn the marketSheath-Ruby 10L697233785Sheath022NMOn the marketSheath-sys 20L697233785Sheath022NMOn the market