- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 4, 2026
B-06976202763071SARS-CoV-2 Ag Rapid Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Greylynx Biotech Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976202763071GISARSg-702(01)06976202763071
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POC1 warning recorded — scroll inside the panel to see all entries.
CN-MF-000032462Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
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 →B-06976202762838On the marketS.pneumoniae Rapid TestB-06976202762203On the marketS.pneumoniae/L.pneumoohila Combo Rapid TestB-06976202763262On the marketSARS-CoV-2 Ag Saliva Rapid TestB-06976202763064On the marketSARS-CoV-2 IgM/IgG Rapid TestB-06976202763057On the marketSARS-CoV-2/Flu A/Flu B Ag Rapid TestB-06976202763040On the marketCertificate health across this manufacturer's portfolio.
IX 2566030-1IssuedHX 2566030-1IssuedNotified 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.