Saudi Arabia SFDA registration ME0000001893SFDAA00007Active

BIOGIOX SARS-CoV-2/Influenza A/B Virus Antigen Rapid Test Kit

Name: BIOGIOX SARS-CoV-2/Influenza A/B Virus Antigen Rapid Test Kit — SFDA registration ME0000001893SFDAA00007
Creator: Shanghai BioGerm Medical Technology Co., Ltd.
Keywords: BIOGIOX SARS-CoV-2/Influenza A/B Virus Antigen Rapid Test Kit, ME0000001893SFDAA00007, 4.0, IVD, SFDA registration

Saudi ArabiaIVDShanghai BioGerm Medical Technology Co., Ltd.4.0

VerifiedSFDA · official registry

Product information

intended to be used alone for in vitro qualitative detection of SARS-CoV-2 antigen, influenza virus

Device classification

Risk Class: 4.0
Product Category: IVD
Product Type: 2

Registration information

Registration ID: ME0000001893SFDAA00007
Authorization ID: MDMA-2-2024-3146
Status: Active
Expire Date: November 08, 2027

Manufacturer

Manufacturer Name: Shanghai BioGerm Medical Technology Co., Ltd.

Model information

IS-MY-010-1-01-SAU, IS-MY-010-5-01-SAU, IS-MY-010-20-01-SAU,IS-MY-010-50-01-SAU,IS-MY-010-1-02-SAU, IS-MY-010-5-02-SAU,IS-MY-010-20-02-SAU, IS-MY-010-50-02-SAU

Product accessories

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About this record

Access comprehensive regulatory information for BIOGIOX SARS-CoV-2/Influenza A/B Virus Antigen Rapid Test Kit in the Saudi Arabia medical device market through Pure Global AI's free database. This 4.0 device is registered with Saudi Arabia SFDA under registration number ME0000001893SFDAA00007 and manufactured by Shanghai BioGerm Medical Technology Co., Ltd..

This page provides complete registration details including product category (IVD), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.