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

Manufacturer and brand owner in Nantong, Jiangsu, China. 11 device types, 19 products catalogued, 1 clearance.

Registry build 21.09.26

Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Clinical Sample Concentrator, Fluorometer, For Clinical Use and 9 other device types. 19 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.

11device types registered with the FDA
19products catalogued under its own name
1510(k) clearance

Registration

FDA registration record for Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.
Registered name JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.
Status Registered
Registration expires 2026
Registration number 3016733849
FEI number 3016733849
DUNS 560300737
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.
Chinese legal name 江苏宏微特斯医药科技有限公司
Unified social credit code 91320623MA1MKF9Q90
Source NMPA UDI database

Location

Address of Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.
City Nantong
Province Jiangsu
Address No.888, Zhujiang Road, Juegang Street, Rudong County
Postal code 226499
Country China

What It Makes

Device types Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Antigens, All Groups, Streptococcus Spp. Class 1 Group A Streptococcus Antigen Detection Kit (Immunochromatography), Group B Streptococcus Antigen Detection Kit (Immunochromatography) 2022 6
Antigens, Ha (Including Ha Control), Adenovirus 1-33 Class 1 Adenovirus Antigen Detection Kit (Immunochromatography), Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) 2022 2
Clinical Sample Concentrator Class 1 Macro & Micro-Test Automatic Nucleic Acid Extractor, Macro & Micro-Test Sample Release Reagent, Macro & Micro-Test Viral DNA/RNA Kit 2022 27
Container, Specimen, Non-Sterile Class 1 Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit 2022 115
Fluorometer, For Clinical Use Class 1 Macro & Micro-Test Fluorescence Reader, Macro & Micro-Test Fluorescence Immunoassay Analyzer 2022 5
Immunoassay, Insulin-Like Growth Factor Binding Protein-1 Class 1 Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochromatography) 2022 4
Instrumentation For Clinical Multiplex Test Systems Class 2 Easy Amp Real-time Fluorescence Isothermal Detection System, EudemonTM AIO800 2022 9
Kit, Test, Pregnancy, Hcg, Over The Counter Class 2 Macro & Micro-Test HCG Preganancy Test Midstream 2023 30
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Class 1 Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR), Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus, Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) 2022 2
Reagents, Clostridium Difficile Toxin Class 1 Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography) 2022 1
Test, Luteinizing Hormone (Lh), Over The Counter Class 1 Macro & Micro-Test LH Test 2023 38

Own-Brand Listings

Clearances

510(k) clearances naming Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K230741 2023-10-13 LCX Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.
Founded 2010
Employees 200+
Factory area 24000 m²
Main products PCR systems, Diagnostic reagents, Immunochromatography tests, Detection kits
Certifications NMPA, CE, FDA 510k, ISO13485, ISO9001
Export markets 28+ languages supported, global reach

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer