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EUDAMED last updated this device on Jun 11, 2026
B-06936983126199Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936983126199IRAC-625CN-MF-000010710(01)06936983126199
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 Ireland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | — | Still on market |
| Spain | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105040699VIRAL ANTIGEN/ANTIBODY DETECTION - OTHERPrimary 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 →Certificate health across this manufacturer's portfolio.
V76 095123 0019SupplementedV76 095123 0020SupplementedEU-QMS-FI-08820-800081-2026IssuedEU-TDA-FI-51326-800081-2026IssuedEU-QMS-FI-08820-800081-2026IssuedCN26/00001622Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
6970277510015EY7On the marketPrueba de infecciones del tracto urinarioB-06936983126298On the marketPrueba de infecciones del tracto urinarioB-08436592551156On the marketPrueba Rápida de antígeno de H. Pylori en caseteB-06936983126120On the marketPrueba Rápida de Combinación deNorovirus+Rotavirus+Adenovirus+ Astrovirus en CaseteB-06936983126113On the marketPrueba Rápida de HBsAg en CaseteB-08436592551378On the market