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:
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. |
*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.