KAIWOOD

Company Profile

Company Profile

Overview:
 KAIWOOD Technology Co., Ltd. is located in the Southern Science Park of Taiwan. It is a professional testing equipment manufacturer integrating biomedical optoelectronics, precision machinery, software design and other technologies. In recent years, it has been committed to the product development and mass production in the biotechnology and medical industry. Focus on the development, production and sales of rapid test reader, take advantage of customization capabilities, and use machine vision with nano-colloidal gold testing technology to provide simple, fast and convenient testing instruments for the biotechnology industry. Product applications for academic research, medical treatment, food safety, pesticide residues, drugs of abuse, health care prevention, and animal disease testing and other fields.

History:
2001 Company established in Taipei, Taiwan.
2002 Stationed in the South Science Park in Tainan, Taiwan.
Provide software/hardware automation system integration services.
2003 Obtained the 2nd National Innovation Award - Biochip Analyzer.
2004 Develop small biomedical testing equipment.
2005 Obtained the National Biotechnology and Medical Quality Award-Chemical Luminometer.
Obtained ISO 9001 certification.
The first time participated in MEDICA in Dusseldorf, Germany.
2006 Develop the Windows series of rapid test readers.
Obtained ISO 13485 certification.
2007 Obtained Taiwan GMP certification: Rapid Test Reader, Chemical Luminometer.
2008 Mass production of CHR-100 and CHR-200R rapid test readers.
2011 Built a reagent factory and obtained ISO 13485 certification.
2012 All reagent items had obtained GMP certification in Taiwan.
Started mass production of CHR-110R rapid test reader.
The products were distributed to dozens of inspection institutes in Taiwan.
2013 Mass production of Android series rapid test reader: CHR-310 and CHR-631
2014 Use the brand of "EASEmed" to market rapid test reagents.
2015 Developed a series of hypochlorous acid products: Toadstools OUT
2016 Develop MCU self-testing series products.
The verification unit of quality management system was transferred from SGS to BSI.
2017 Self-testing products had obtained CE certifications.
2018 Obtained the new ISO 13485:2016 and ISO 9001:2015 certificates.
2019 The products of self-testing series had passed the registration in Taiwan, and completed the US FDA Listing.
In vitro diagnostic reagents for drug abuse (MET, MOR, KET, MET/MOR combo) were approved for sale to general staff and professionals.
2020 The COVID-19 broke out globally, and the Toadstools OUT hypochlorous acid products were sold in hypermarkets and major shopping platforms.
The quality management system had passed the factory audit and social responsibility audit of manufacturers such as RT-Mart/Carrefour, and officially provided OEM services for the above-mentioned manufacturers of customer trademark products.
Participated in Taiwan Medical Technology Exhibition.
2021 Carried out transnational cooperation with foreign manufacturers, integrate the products (reader& reagents) of both parties, and applied for the US FDA 510(k) pre-market notification in a detection system.
Participated in Taiwan Medical Technology Exhibition.
2022 Supported EUA OEM production of COVID-19 testing reagents.
All products had obtained QMS certification in Taiwan.
2023 Successfully completed the registration as a Foreign Manufacturer with the Japanese PMDA (Pharmaceuticals and Medical Devices Agency) and obtained approval for medical device market notification.
Obtained Dun & Bradstreet (D-U-N-S) certification.
Supported for student laboratory courses at the Department of Medical Laboratory Science and Biotechnology of National Cheng Kung University.
2024 Achieved CE certification under the EU IVDR for the handheld rapid test reader, obtaining market access in the European Union.
Supported for student laboratory courses at the Department of Medical Laboratory Science and Biotechnology of National Cheng Kung University.
Prospect:  KAIWOOD will continue to accumulate patents and key technologies, enhance its competitive advantages and core technologies, and become a supplier of all-round medical equipment research and development, manufacturing, production, and reasonable prices. KAIWOOD focuses on the needs of customers and the market, develops equipment and services according to the actual needs of customers, grows and thrives together with customers, and achieves the goal of “precision, speed and low cost”. Product Advantages :  KAIWOOD committees to the cross-field cooperation in the field of biomedicine, and extends KAIWOOD’s product and service scope upstream and downstream in series to create a situation of mutual prosperity and win-win.

*KAIWOOD has ISO, FDA, CE, FCC and other quality and product certifications. It is a professional medical equipment factory that can meet customers’ related medical needs. *Possess experience in cooperating with dozens of reagent manufacturers and R&D departments at home and abroad. *Has rich experience in customized R&D. *As a collector of detection data, it is the cornerstone of smart health care.