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EUDAMED last updated this device on May 9, 2026
B-06974566302967Rotavirus Group A Antigen Rapid Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhuhai Encode Medical Engineering Co., Ltd.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974566302967W0105040606(01)06974566302967
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105040606ROTAVIRUSCN-MF-000019361Primary placement in Ireland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | May 26, 2022 | Dec 30, 2027 |
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 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-06974566303759On the marketRespiratory Pathogen Antigen Rapid TestB-06974566303766On the marketRotavirus and Adenovirus Antigen Rapid TestB-06974566302974On the marketRotavirus Group+Adenovirus+Norovir us G1+Norovirus GII combo Rapid TestB-06974566302950On the marketRSV Rapid TestB-06974566302943On the marketS. typhoid/ S. Paratyphi rapid testB-06974566302936On the marketNo certificate specifically references this device's Basic UDI-DI.