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EUDAMED last updated this device on Sep 29, 2022
B-06974849366082SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000012807(01)06974849366082
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1. This product is only used for in vitro diagnosis. 2. For professional use only.
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.
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 Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974849366082Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06974849366082HWTS-RT062AUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105099099VIROLOGY - RT & POC - 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 →B-06974849366075On the marketSARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)B-06974849366129On the marketSARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)B-06974849366099On the marketSARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-SalivaB-06974849366518On the marketSARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-SalivaB-06974849366501On the marketSARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-SalivaB-06974849366495On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
EU-QMS-FI-56762-800162-2026IssuedNotified 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.
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