EUDAMED update: Mar 16, 2026

Shenzhen Reagent Technology Co., Ltd.

CN-MF-000047757

Active15 devices

Address: Room 1601, Building No.3, YESUN INTELLIGENT COMMUNITY I, No.1301-77, Guanguang Road, 518128 Shenzhen
Role: Manufacturer
Date of registration: May 12, 2025
Country: China

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Shenzhen Reagent Technology Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 15 devices on the EU market across 3 countries. Headquartered in Shenzhen, China. Explore the regulatory profile, devices and certificates on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED update: Mar 16, 2026

Shenzhen Reagent Technology Co., Ltd.

CN-MF-000047757

Active15 devices

Address: Room 1601, Building No.3, YESUN INTELLIGENT COMMUNITY I, No.1301-77, Guanguang Road, 518128 Shenzhen
Role: Manufacturer
Date of registration: May 12, 2025
Country: China

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About REAGEN

SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: CN-MF-000047757
Role: Manufacturer
Country: China
Organization name: Shenzhen Reagent Technology Co., Ltd.
EU VAT number: 914403006911615909
Trade register: 914403006911615909
Date of registration: May 12, 2025

Contact details for REAGEN

Phone: +1 619-3898888
Email: info@reagenus.com
Website: www.reagen.us
Address: ROOM 1601, BUILDING NO.3, YESUN INTELLIGENT COMMUNITY I, NO.1301-77, GUANGUANG ROAD LONGHUA DISTRICT 518128 SHENZHEN CHINA

Competent authority

Name: Agencia Española de Medicamentos y Productos Sanitarios
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: ES-CA-010
Phone: +34 (91) 822 5274
Email: sgps@aemps.es

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
COVID-19 & Influenza A/B Antigen Combo Test Kit	`RNS92048C`	`06974443200034`	1	On the market
Eleven Respiratory Pathogens Antigen Rapid Test Kit	`RNS92111`	`06974443201703`	1	On the market
Eleven Respiratory Pathogens Antigen Rapid Test Kit （NPS)	`RNPT98811-20`	`06974443200867`	1	On the market
Hantavirus IgG/IgM Antibody Rapid Test Kit	`RNPT96027-20`	`06974443201826`	1	On the market
Hantavirus IgG/IgM Antibody Rapid Test Kit	`RNPT96027-01`	`06974443201819`	1	On the market
Nine Respiratory Pathogens Antigen Rapid Test Kit	`RNS92190`	`06974443201710`	1	On the market
Nine Respiratory Pathogens Antigen Rapid Test Kit	`RNS92190`	`06974443200423`	1	On the market
SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit	`RNS92146`	`06974443201451`	1	On the market
SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit	`RNS92146`	`06974443201406`	1	On the market
SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit	`RNS92131`	`06974443200027`	1	On the market
SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit	`RNS92131`	`06974443201499`	1	On the market
Ten Respiratory Pathogens Antigen Rapid Test Kit	`RNS92110`	`06974443201697`	1	On the market
Ten Respiratory Pathogens Antigen Rapid Test Kit	`RNS92110`	`06974443200850`	1	On the market
TriClear CA/TV /GV Antigen Combo Rapid Test Kit	`RNS92331`	`06974443201468`	1	On the market
Twelve Respiratory Pathogens Antigen Rapid Test Kit	`RNS92343`	`06974443201611`	1	On the market

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
COVID-19 & Influenza A/B Antigen Combo Test Kit	`RNS92048C`	`06974443200034`	1	On the market
Eleven Respiratory Pathogens Antigen Rapid Test Kit	`RNS92111`	`06974443201703`	1	On the market
Eleven Respiratory Pathogens Antigen Rapid Test Kit （NPS)	`RNPT98811-20`	`06974443200867`	1	On the market
Hantavirus IgG/IgM Antibody Rapid Test Kit	`RNPT96027-20`	`06974443201826`	1	On the market
Hantavirus IgG/IgM Antibody Rapid Test Kit	`RNPT96027-01`	`06974443201819`	1	On the market
Nine Respiratory Pathogens Antigen Rapid Test Kit	`RNS92190`	`06974443201710`	1	On the market
Nine Respiratory Pathogens Antigen Rapid Test Kit	`RNS92190`	`06974443200423`	1	On the market
SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit	`RNS92146`	`06974443201451`	1	On the market
SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit	`RNS92146`	`06974443201406`	1	On the market
SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit	`RNS92131`	`06974443200027`	1	On the market
SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit	`RNS92131`	`06974443201499`	1	On the market
Ten Respiratory Pathogens Antigen Rapid Test Kit	`RNS92110`	`06974443201697`	1	On the market
Ten Respiratory Pathogens Antigen Rapid Test Kit	`RNS92110`	`06974443200850`	1	On the market
TriClear CA/TV /GV Antigen Combo Rapid Test Kit	`RNS92331`	`06974443201468`	1	On the market
Twelve Respiratory Pathogens Antigen Rapid Test Kit	`RNS92343`	`06974443201611`	1	On the market

Shenzhen Reagent Technology Co., Ltd.

Shenzhen Reagent Technology Co., Ltd.

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