GONGDONG MEDICAL

A CHINA INDUSTRY-LEADING MANUFACTURER OF IVD/LAB PLASTIC DISPOSABLES

Est. 1985, GongDong Medical has been a industry-leading manufacturer of IVD/Lab consumables in China. 38 Years of company history as an industry-leading manufacturer of laboratory and medical consumables in China.

President of Mr. Shy was named "The Leading Person in 2019 IVD Industry" by China Association of In Vitro Diagnostics, IVD Branch of China Association for Medical Devices Industry, and Professional Community of Experimental Medicine.

GongDong Medical was awarded "Prize of Excellence in Contribution" for its long-term achievements by CAIA and CCCMHPIE.

There are 5 sites of production and molding tools plants in China and US makes GongDong a reliable global supply chain partner for brands.

3 PRODUCTION SITES IN CHINA, 93,000㎡  IN SIZE

All facilities are 1,220,000 ft² (93,000 m²) in size, has approximately 300 injection molding machines, 1,800 employees and are all certified to ISO 13485:2016, including 35,000 m² of Class 100,000 and 300,000 cleanrooms, producing over 400 categories and 3,000 SKUs.

US FACTORY

The US facility is a 100,000-sq.-ft. building.  It currently houses 52 machines, consisting of tonnage from 7 to 500 ton electric machines and is ISO 13485 certified also.

MOLDING TOOLS PLANT

China's top class environment-controlled in-house molds & tools manufacturing plant, provides solutions for varied high-end OEMs of all sizes consumable projects which has the necessity to increase its current productivity and supply, reduce production costs, shorten global supply chain.

1.19 Billion RMB Sales Revenue In 2021（170millions USD).

41% of Laboratory consumables.

1.85 Billion USD market capitalization among China-listed companies.

Above 300 Sets of injection molding tools for only internal use can be made every year with 35-year experience focusing on laboratory and medical products.

In-house environment-controlled injection molding tools making plant, operated by top technical experts and staffs with over 10-year experiences, equipped with Japan Mazak, Makino, FANUC, Sodick CNC and EDM tools making machines, and HEXAGON Global-S, MITUTOYO analyzers.

PROCESS VALIDATION AND CAPABILITY

GongDong Medical has rich experiences in following through requirements of process validation of FAT, SAT, IQ, OQ, PQ, to get safe, effective medical products to the market for customers, and CPK shall not be less than 1.33 during OQ, PQ.

4-CELL LINES TESTING FOR CELL CULTURING PRODUCTS

Cell culturing products in USP VI polystyrene materials will be also tested and qualified with 4 cell-lines testing to ensure monolayer formation and uniform cloning efficiency.

PACKAGING VALIDATION & STERILIZATION

In the case of packaging and sterilization, GongDong Medical provides highly customized service and all final designs should be going through ISTA test. EOG, EB, Gamma sterilization available and all sterile products have  dose setting/dose mapping plan and validation tracking records.

Labs in GongDong has ability of testing microorganisms, DNase-free, RNase-free, Cytotoxin free products and those 3 testing will be implemented for every batch of production.