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EUDAMED last updated this device on Apr 22, 2026
B-GKPD125XEMERS-CoV Antigen Rapid Test Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Dezhou Guoke Medical Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-GKPD125XEGKPD125D-GKPD125XE
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POCCN-MF-0000441281 warning 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.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
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 →B-GKPD114X9On the marketMalaria Pf Antigen Rapid Test Cassette(Colloidal Gold)B-06977698401683On the marketMalaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold)B-06977698401744On the marketMicroalbuminuria (MAU) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)B-06977698402734On the marketMpox Virus Ag Rapid Test KitB-GKPD123XAOn the marketMpox Virus IgG/IgM Ab Rapid Test KitB-GKPD124XCOn 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.No certificate specifically references this device's Basic UDI-DI.