Taihao Bio Secures First Class III Medical Device Approval for TurboFlow X100 Nucleic Acid Analyzer, Marking Breakthrough in Clinical Precision Diagnostics

Recently, Beijing TAIHAO BIOTECH Co., Ltd. (hereinafter referred to as “TAIHAO BIOTECH”) has successfully obtained the Class III Medical Device Registration Certificate (National Medical Device Registration No. 20253222566) for its product, the “Isothermal Amplification Microfluidic Chip Nucleic Acid Analyzer (Model: TurboFlow X100).”This marks the first Class III medical device registration certificate obtained by TAIHAO BIOTECH since its establishment, representing a significant milestone in the company’s development. It not only signifies a key breakthrough in the field of clinical precision diagnostics but also injects strong new momentum into the large-scale clinical application of microfluidic biochip technology through hard-core technological innovation.

Since its establishment in 2021, TAIHAO BIOTECH has grown into a National High-Tech Enterprise and a Beijing “Specialized, Refined, Differential, and Innovative” (SRDI) SME after four years of development. The company remains dedicated to the innovative research and development of fully integrated microfluidic chip technology and novel rapid biological molecular detection technologies, aiming to address practical pain points in the medical diagnostics field through technological breakthroughs.

Specifically,In clinical diagnosis and disease control screening scenarios, traditional nucleic acid testing has long faced multiple challenges.: Reliance on specialized laboratories and complex equipment imposes high demands on capital investment and the professional expertise of medical technicians, making it difficult for primary healthcare institutions to implement. The testing process is cumbersome, requiring manual reagent addition and stepwise operations, which are prone to human error. Single-target detection offers low efficiency and fails to meet the needs for multi-etiology screening in complex infectious diseases. The long turnaround time, often taking several hours or even longer, delays clinical diagnosis and treatment decisions. Additionally, insufficient sensitivity of some testing equipment may lead to the risk of false negatives. These pain points severely constrain the effectiveness of nucleic acid testing in scenarios such as rapid diagnosis and widespread adoption at the primary care level, posing an urgent challenge for the healthcare industry to resolve.

As a landmark achievement of TAIHAO BIOTECH's core technology platform,The TurboFlow X100 Nucleic Acid Analyzer precisely addresses the aforementioned industry pain points by simplifying and upgrading the nucleic acid testing process, which originally relied on professional laboratories, to a fully automated procedure performed entirely within an integrated microfluidic chip, thereby highlighting its core advantages.：

Breaking Through Scenario Limitations: The fully integrated design pre-loads all reaction reagents within the chip, eliminating the need for specialized laboratory support. This enables rapid deployment in settings such as primary healthcare institutions and emergency screening, freeing nucleic acid testing from site constraints.

Simplifies complex operations: One-click initiation fully automates the detection process, eliminating the need for manual, stepwise reagent addition. This significantly lowers the operational barrier and reduces human error, thereby enhancing the standardization and stability of the testing workflow;

Breaking Through Efficiency Bottlenecks: Complete the Entire Testing Process Within 45 Minutes, Securing Critical Time for Early Diagnosis and Timely Treatment of Infectious Diseases;

Addressing Screening Gaps: Supports simultaneous detection of up to 60 targets, enabling comprehensive coverage of multiple pathogens in a single test. It is ideally suited for etiologic investigation of complex infectious diseases such as respiratory tract infections, thereby minimizing missed detections and misdiagnoses.

Ensuring Precise Results: With a limit of detection as low as 50–200 copies/mL, the assay offers high sensitivity and specificity, enabling accurate capture of trace nucleic acid samples and effectively reducing the risk of false negatives.

Behind the Approval of the Class III Medical Device Registration Certificate Lies TAIHAO BIOTECH’s Profound Accumulation.

From a hardware perspective, TAIHAO BIOTECH is located in the Beijing Changping International Information Industry Base, possessing> 1,500+ sqm R&D and Pilot-Scale Platform, and invested in the construction of projects in Linyi, ShandongOver 5,000 square meters of specialized microfluidic chip production base, equipped with a P2 biosafety laboratory, bacterial and viral strain repository, and Class III medical device production workshop, laying a solid foundation for technology transfer and scaled production.

From the perspectives of technological R&D and quality control,, TAIHAO BIOTECH has cumulatively won20+ Independent Intellectual Property Rights, establishing a robust technical barrier. Meanwhile,Dual Certified with ISO 13485 Medical Device Quality Management System and ISO 9001 Quality Management System, TAIHAO BIOTECH ensures the standardization and reliability of its products throughout the entire process from research and development to production.

From the perspectives of investment and collaboration,, the company has secured investment and recognition from multiple professional institutions, including the Zhongguancun Collaborative Innovation Fund, Shenzhen Dayi Capital, and Shanghai Shanda Investment. Meanwhile, it has established in-depth collaborations with numerous domestic universities, research institutes, national-level organizations, and top-tier Grade A tertiary hospitals, accelerating collaborative innovation across industry, academia, research, and application, as well as the commercialization of scientific and technological achievements.

With the approval of the TurboFlow X100 Nucleic Acid Analyzer as a key opportunity, TAIHAO BIOTECH will accelerate the clinical implementation of this product, ensuring that its core technological achievements effectively serve medical institutions at all levels and disease control screening scenarios, thereby providing the healthcare industry with more efficient, convenient, and precise testing solutions.

In the future, TAIHAO BIOTECHWe will continue to increase R&D investment and advance the iterative upgrades of high-performance microfluidic devices and detection chips,Further expand the application scenarios of our products across multiple fields, including clinical diagnostics, disease control screening, and veterinary medicine, continuously empowering the high-quality development of the healthcare industry with robust, innovative technologies.