- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 16, 2026
B-06978896416448COVID-19 (SARS-CoV-2) Antigen Test Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06978896416448W-Ag03-01CN-MF-000019908(01)06978896416448
1 warning recorded — scroll inside the panel to see all entries.
CW018Sterile
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 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105041101CORONAVIRUS AGPrimary 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.
HX 2055510-1AmendedIX 2055510-1IssuedNotified 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.
B-06978896413614On the marketCoaguDx Quality ControlB-06978896413638On the marketCoaguDx Quality ControlB-06978896413645On the marketCOVID-19 (SARS-CoV-2) Antigen Test KitB-06978896416479On the marketCOVID-19 (SARS-CoV-2) Antigen Test KitB-06978896416707On the marketCOVID-19 (SARS-CoV-2) Antigen Test KitB-06978896416653On the market