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Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Manufacturer in China

EUDAMED update: Nov 29, 2023

JM

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

China

All roles followed

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Sources: EUDAMED

Legal information of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Legal name: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
EU VAT number: 91320623MA1MKF9Q90
SRN (displayed role): CN-MF-000012807
EUDAMED status: Active· registered in 2021
Registered office: Zhujiang Road, Juegang Street, Rudong County (Life & Health of Rudong High-tech Zone), No. 888 226499 Nantong City, Jiangsu, China

Contact details for Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Email: marketing@hongweitest.com
Address: NO. 888, ZHUJIANG ROAD, JUEGANG STREET, RUDONG COUNTY (LIFE & HEALTH OF RUDONG HIGH-TECH ZONE) 226499 NANTONG CITY, JIANGSU CHINA

Data export

Export the 204 devices of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

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Medical device manufacturers in EUDAMED

Certificates of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Competent authority for Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

DE/CA05 - Behorde fur Justiz und Verbraucherschutz
GermanyContact the authority →

Related documents of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Quality management system

Certificate EU-QMS-FI-56762-800162-2026

Issued

Manufacturer

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Notified body

Sertio Oy

3018

Version

1

Valid from

7/9/2026

Valid until

7/9/2031

Executives & regulatory representatives of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

2 contacts identified

WANG Pengzhi
PRRC
View profile →
WANG Pengzhi
Hidden

Cartography of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Authorised representativeNotified bodiesPeople

Sertio Oy — 1 certificate — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Shanghai International Holding Corp. GmbH(Europe) — represents — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
CMC Medical Devices & Drugs SL — represents — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
WANG Pengzhi — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

204Total Devices

138Basic UDI-DIs

1Certificates1 valid · 0 expiring < 12 months

2CountriesEU/EEA placements

Market presence of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Devices placed in 2 countries

Spain120
Germany84

Risk categories of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Catalog of Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

204 devices · 138 families

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Easy Amp Real-time Fluorescence Isothermal Detection System (HWTS 1600)HWTS 1600P,HWTS 1600S3 versions
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus1 version
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus1 version
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus1 version
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Plasmodium50 tests/kit1 version
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)10 tests/kit1 version
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)50tests/kit1 version
Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens50tests/kit1 version
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)1 test/kit (Speichel)1 version
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)10 tests/kit (Speichel)1 version
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)20 tests/kit (Speichel)1 version
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)1 test/kit (Rachenabstrichen)1 version
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)1 test/kit (Nasal Swab)1 version
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)1 test/kit (Nasopharyngeal swab)1 version
SARS-CoV-2 Virus Antigen Detection Kit (Immunofluorescence Chromatography)20 tests/kit1 version
Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody96 tests/kit1 version
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2)16 tests/kit1 version
Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)50 tests/kit1 version
Real-time fluorescent RT-PCR kit for detecting SARS-CoV-250 tests/kit1 version
Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Neutralization Antibody96 tests/kit1 version
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans50 tests/kit1 version
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus50 tests/kit1 version
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)1 test/kit1 version
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)20 tests/kit1 version
SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR) 50 tests/kit1 version

138 families

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