News | Hukui Biotechnology Co., Ltd

″HUKUI Partners with U.S. Company EyeZense Inc. to Develop Innovative Smart Security Wearable Devices and Real-time AI Image Recognition Systems”

Media, News2023 年 10 月 20 日

HUKUI Biotechnology Co., Ltd. (referred to as HUKUI), a leading global medical electronics manufacturing service provider, has formally partnered with the Silicon Valley-based smart wearable equipment company, EyeZense Inc., in a strategic development collaboration. This partnership leverages HUKUI’s expertise in miniature endoscopic lenses to jointly design and manufacture intelligent security wearable camera devices. In alignment with industry trends, they will…

HKBio Partners With Brain Navi Biotechnology Co., Ltd. to Co-develop Robot-assisted Brain Endoscope

Media, News2022 年 3 月 30 日

Founded by the Chairman John Hsuan 8 years ago, HKBio has spent years honing the expertise in regulatory consultation, product registration services, and contract design and development services for medical device products. HKBio has announced this month that it has partnered with Brain Navi Biotechnology to co-develop a robot-assisted brain endoscope, helping surgeons safely, swiftly and accurately to place endoscopes…

Single-use Medical Devices Are Transforming the Industry

News2022 年 3 月 4 日

As the COVID-19 outbreak has spread in the past 2 years, the global healthcare providers have been experiencing severe operational and clinical challenges, including routine appointment and surgery cancellations, cross infections between patients and caregivers, and hospital staff shortage. This had a great impact on the utilization and procurement of diagnostic devices and surgical instruments.

HKBio From 2021 to 2022

News2022 年 2 月 16 日

Established by the Chairman, John Hsuan, 8 years ago, HKBio has delved into the regulatory services and contract design and manufacturing services for almost a decade. In 2021, HKBio had a record-breaking year due to the rapid growth in Taiwanese corporate rapid testing needs and sales growth in China, achieving more than 6 fold annual revenue growth and quarterly break-even…

What’s a CDMO with a VC mindset?

News2022 年 1 月 29 日

Medical device design and development are highly technical and specialized. It is even more challenging for an early stage medical device startup to have the necessary resources to build an end-to-end manufacturing facility, from small scale prototypes to large scale mass production, not to mention the cost of clinical trial and patent maintenance. This is exactly the reason why medical…

What is CDMO in the Medical Device Industry?

News2021 年 12 月 12 日

A few decades ago, medical device OEMs single-handedly developed and manufactured their medical innovations. The advantage of this kind of operation is the ability to have complete control over design and development, small pilot production, and large scale mass production. However, a large-scale ISO13485 compliant GMP manufacturing facility represents an enormous capital commitment.

Medtech Service Provider HuKui Bio raised US$5.5M for US market expansion

Media2021 年 1 月 16 日

The medtech service provider Hukui Bio (互貴興業) announced that it has raised US$5.5 million in Series C funding, led by Yellowstone Holding AG from Switzerland, totalling US$11.8M funding to date. HuKui Bio will collaborate with venture capital funds in the Bay area, in addition to the biomedical innovation clusters and accelerators in Europe and the US. The New Business Department…

We Are Fighting The COVID-19 Threats !

Media2020 年 6 月 12 日

In 2020, the epidemic of COVID-19 has spread in the whole world, and COVID-19 diagnostic kit is definitely a purchasing point from the beginning. Hukui Bio has been authorized bytwo Taiwan nucleic acid diagnostic kit factories to begin providing COVID-19 diagnostic kit for Europe, ASEAN and South America markets, hoping to satisfy their local medical resources.

Cymmetrik and HUKUI Tech Work Together to Take AcuSense BioMedical Entering China Market

Media2020 年 4 月 9 日

“Blood Leakage Detection System”, developed by AcuSense BioMedical Technology Corp. (AcuSense), is a specific medical device designed for kidney disease patient to reduce the risk of dialysis treatment. Through the cooperation with HUKUI Tech, the subsidy of Hukui Biotechnology Co., Ltd., AcuSense is going to expand its business to China. HUKUI Tech integrates product authorization, registration, production and distribution as…

HUKUI Bio is Integrating its Network and Arranging Resource for Novel Coronavirus (COVID-19) Diagnostic Kit Supply Chain

News2020 年 4 月 9 日

In 2020, the epidemic of COVID-19 has spread in the whole world, and COVID-19 diagnostic kit is definitely a purchasing point from the beginning. HUKUI Bio has been authorized by two Taiwan nucleic acid diagnostic kit factories to begin providing COVID-19 diagnostic kit for Europe, ASEAN and South America markets, hoping to satisfy their local medical resources.

Notes for Registration in China

Knowledge Center2020 年 1 月 4 日

What are the central authorities in charge of medical devices in various countries? United States Food and Drug Administration (FDA) Attached to United States Department of Health, Education, and Welfare, is in charge of the administration of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies throughout the country. Taiwan Taiwan Food…

Clinical Guidelines in China

Knowledge Center2020 年 1 月 3 日

Are clinical trials necessary for medical devices to enter China? According to the 2018 announcement on the latest “Catalogue of medical devices exempted from clinical trials” (No. 94, 2018) and “Catalogue of IVD reagents exempted from clinical trials”, when the product description conforms to the medical devices or IVD reagents of the specification on the…

Policy Guidelines in China

Knowledge Center2020 年 1 月 2 日

What are the norms for setting up a medical device factory in China? Good Manufacturing Practice for Medical Devices and YY0287-2017-Medical Devices-Quality Management Systems-Requirements for regulatory purposes / ISO 13485:2016 need to be followed. What is the current situation of centralized procurement of medical consumables? In March 2018, China changed the National Health and Family…

Innovative Medical Devices in China

Knowledge Center2020 年 1 月 1 日

What are innovative medical devices? The core technology of the product has Chinese patent right for invention, or the application for invention patent has been reported to the Patent Administration Department under the State Council of China. The main working principle or action mechanism of the product is the first in China, and the product…

HUKUI Bio Has Obtained Its First In Vitro Diagnostic Device License in China

Media2019 年 1 月 19 日

HuKui Biotechnology Co., Ltd.(HUKUI Bio) announced that its wholly-owned subsidiary HuKui Technology Co., Ltd.(HUKUI Tech), has officially acquired the Class II Medical Device Registration License from Chongqing Municipal Drug Administration in China for two products: blood glucose test strip and uric acid test strip, on January 8th. It is the first time a manufacturer obtaining…

The Hukui Biotechnology Corporation in Collaboration with the Zhongguancun Medical Engineering Transformation (Chongqing) Center to Obtain a Category III License from the CFDA for Medical Equipment

Media2017 年 6 月 20 日

The Hukui Biotechnology (Chongqing) Corporation, the subsidiary of Hukui Biotechnology Corporation, signed the Cooperation Framework Agreement with the Zhongguancun Medical Engineering Transformation (Chongqing) Center to promote the development of the biotechnology industry. The goal of the Agreement is to create a biotech incubator platform that promotes the smart medical industry focusing on the development of medicine, top-of-the-range medical equipment, testing…

Compal Group cooperate with Hukui Biotechnology Corporation to Enter Medical Market in China

Media2017 年 6 月 13 日

Taipei, Taiwan, June 13, 2017 General Life Biotechnology Co., Ltd., an affiliate of Compal Group (TWSE:2324), has signed a contract with Hukui Biotechnology Corporation. General Life Biotechnology Co., Ltd. will provide the key components and technical support, and Hukui Technology, the Chongqing-based subsidiary of Hukui Biotechnology Corporation is then responsible to apply for the license…

First BMS Partner

Media2017 年 3 月 30 日

The Taiwan Carbon Nanotube Technology Corporation (TCNT) announced Wednesday (2017/03/29) that it has inked a BMS(Biotech Manufacturing Services) contract and marketing memorandum of understanding (MOU) with HuKui.

UMC’s John Hsuan eyes biotech market across strait

Media2016 年 8 月 16 日

Taiwan’s high-tech guru John Hsuan (宣明智) aims for significant growth in mainland China’s market in order to make the biotech industry the next pride of Taiwan.

UMC’s John Hsuan eyes biotech market across strait

Media2016 年 8 月 16 日

By John Liu, The China Post August 16, 2016, 12:30 am TWN The China PostTaiwan’s high-tech guru John Hsuan (宣明智) aims for significant growth in mainland China’s market in order to make the biotech industry the next pride of Taiwan. The honorary vice chairman of the United Microelectronics Corp (UMC, 聯電), one of Taiwan’s leading high-tech companies, has high expectations…