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EUDAMED last updated this device on Mar 30, 2026
B-GCFC-T503aHGT5Smart Rapid COVID-19 & Flu A/B Ag Test Device 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.
D-GCFC-T503aHGT5GCFC-T503aUS-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.D-GCFC-T503aHGT5
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
3 warnings recorded — scroll inside the panel to see all entries.
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.
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.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090601CORONAVIRUS / INFLUENZA - RT & POCPrimary 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 →B-GCCOV(NAb)-402bHGN8On the marketSHBG ControlB-FKSHB-PN20HGNGOn the marketSHBG Quantitative Test Kit (Time-Resolved FIA)B-FKSHB-402aHG89On the marketSmart Rapid COVID-19 Ag Test DeviceB-GCCOV-503aHG4POn the marketStrep A Antigen Control KitB-GCSTR-PN2HGTHOn the marketStrep A Rapid Test Cassette (Throat Swab)B-GCSTR-502CaHGUHOn the marketNo certificate specifically references this device's Basic UDI-DI.