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EUDAMED last updated this device on May 25, 2026
B-81649002ACAB04D5RDFPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →ACAB04D-BHG48E is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Healgen Scientific Limited Liability Company. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →D-81649002ACAB04D5RDFBasic 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 →B-81649002ACAB04D5RDFACAB04D-BHG48EUDI 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 →D-81649002ACAB04D5RDF
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105070304INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTSSterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
US-MF-000018839No 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.B-81649002SDVS01NJ2ROn the marketACOV01-AHG48E; ACOV01-AHG96EB-81649002ACOV01DTMBOn the marketAMPV01D-AHG48E; AMPV01D-AHG96EB-81649002AMPV01DK32ZOn the marketAFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96EB-81649002AFR01EJB5On the marketADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96EB-81649002ADV01EQC5On the marketAEBV01-AHG48E; AEBV01D-AHG48EB-81649002AEBV01BNGJOn the market