- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Dec 29, 2025
69528048A4791503YCOVID-19 Antigen Rapid Test is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Assure Tech. (Hangzhou) Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06952804832087Format (cassette): A47915; Format (pen): A48410(01)06952804832087
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105099099VIROLOGY - RT & POC - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW009CN-MF-000002170The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
69528048A4A93006WOn the marketColloidal Gold Test Analyzer69528048ACG10000CVOn the marketColloidal Immunoassay Analyzer69528048ADT100JPOn the marketCOVID-19&Influenza A/B&RSV&ADV Antigen combo Test69528048A49330037On the marketCOVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test69528048A4923002YOn the marketCOVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test69528048A4D73007HOn the marketCertificate health across this manufacturer's portfolio.
HX 2074650-1SupplementedIX 2074650-1IssuedNotified 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 →