HUKUI BIOTECHNOLOGY CO., LTD. is a Taiwan-based Contract Development and Manufacturing Organization (CDMO) that specializes in the development of innovative medical devices and digital health solutions. Headquartered in Taipei City, the company is positioned at the intersection of biotechnology, electronics, and clinical application, aiming to revolutionize healthcare through intelligent medical technology.
Core Business and Product Focus
HUKUI Biotech operates primarily as a CDMO partner, providing comprehensive services from R&D and design to manufacturing and regulatory support. The company is focused on next-generation diagnostic and monitoring tools tailored to modern clinical needs, including:
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Wireless Handheld Ultrasound Devices (POCUS):
- Portable ultrasound systems for point-of-care diagnostics
- Enables fast imaging across emergency rooms, primary care, and remote environments
- Supports wireless connectivity, AI integration, and cloud-based storage
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Disposable Medical Endoscopes:
- Single-use endoscopic devices to reduce infection risk
- Cost-effective alternatives to reusable endoscopes in gastroenterology, urology, and ENT
- Designed for compatibility with digital imaging platforms
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Medical-Grade Smart Ring:
- Wearable device for continuous monitoring of vital signs including heart rate, temperature, and oxygen saturation
- Developed for both clinical and consumer health markets
- Syncs with mobile applications and healthcare provider systems
These products align with global trends in portable diagnostics, telemedicine, and home-based healthcare, especially in the post-COVID era.
Specialization and Technological Strength
- Cross-Disciplinary R&D: Combines engineering, biomedicine, and industrial design under one roof.
- Rapid Prototyping: Offers accelerated development cycles for startups and med-tech innovators.
- Regulatory Expertise: Supports clients through Taiwan FDA, US FDA (510(k)), and CE marking processes.
- Customization Capability: Provides OEM/ODM services tailored to specific clinical applications and market needs.
Manufacturing and Facilities
- ISO 13485:2016 Certified manufacturing environment
- Cleanrooms for Class II and III medical device assembly
- In-house electronic component integration, testing, and sterilization processes
- Dedicated lab for signal processing, wireless communication, and firmware development
Market Presence and Export Capacity
- Primary Markets: North America, Japan, Europe, and Southeast Asia
- Devices have been used in both hospital systems and rural clinics
- Export-ready packaging, labeling, and documentation compliant with MDR and FDA standards
Industry Engagement and Innovation
- Selected participant in Taiwan Tech Arena (TTA) for med-tech innovation
- Collaborative projects with leading universities in Taiwan and international hospital systems
- Recognized for excellence in healthcare innovation by Taiwan’s Ministry of Economic Affairs
Capabilities and Services
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End-to-End CDMO Services:
- Concept to commercialization support
- Risk and usability engineering
- Validation and verification (V&V)
- Small- to medium-volume production
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Product Lifecycle Management:
- Iterative design improvements based on clinical feedback
- Post-market surveillance and product updates
- Firmware and app development integration
Certifications and Compliance
- ISO 13485:2016 (Quality Management System for Medical Devices)
- CE Marking for several product lines under the EU MDR framework
- Products developed in accordance with IEC 60601 for electrical medical devices
- FDA Registration for U.S. market access
Testimonials and Impact
Though customer-specific testimonials are not publicly published, HUKUI's reputation in the Taiwanese and international med-tech industry is reflected in:
- Positive case studies of wireless ultrasound deployments in rural and low-resource settings
- Partnerships with digital health platforms for integration of smart wearable data
- Continuous product evolution driven by feedback from healthcare professionals
HUKUI BIOTECHNOLOGY CO., LTD. continues to be a driving force in the convergence of technology and healthcare, offering scalable, intelligent solutions that address real-world clinical challenges while maintaining global compliance and quality standards.
