Asia’s Pioneer Test Lab in Oxygen Desaturation
Hypoxia Laboratory SZU (HLSZU) is a specialized medical device testing laboratory dedicated to advancing pulse oximeter and physiological monitoring technologies through high-quality clinical research and validation studies. Established on July 31, 2020, HLSZU was founded through a collaboration between Shenzhen University General Hospital (SUGH) and the internationally recognized Bickler Hypoxia Laboratory at the University of California, San Francisco (UCSF).
Today, HLSZU is recognized as Asia’s pioneer oxygen desaturation testing laboratory, providing clinical testing services that support medical device manufacturers seeking regulatory approval in global markets. Our laboratory combines international testing expertise with rigorous clinical research methodologies to generate reliable, submission-ready data accepted by regulatory authorities around the world.
International Expertise in Hypoxia Testing
Our partnership brings together the clinical research capabilities of Shenzhen University General Hospital and the world-renowned expertise of the Bickler Hypoxia Laboratory.
For more than 60 years, the Bickler Hypoxia Laboratory has been a global leader in studying the effects of hypoxia on the human body and developing standardized testing methodologies for pulse oximeter validation. The laboratory has supported nearly one thousand medical device manufacturers worldwide and has conducted studies involving more than 10,000 research participants. Its work has helped validate many internationally recognized pulse oximeter brands and has played an important role in shaping modern hypoxia testing standards.
Through this collaboration, Hypoxia Labs provides manufacturers with access to internationally recognized testing methodologies while maintaining the highest standards of clinical quality and scientific integrity.
Specialized Medical Device Testing Services
Our laboratory focuses on physiological monitoring technologies, providing customized testing programs for:
- Hypoxia and controlled desaturation studies
- Pulse oximeter validation
- FDA pulse oximeter testing
- Blood pressure device validation
- Continuous and invasive blood pressure testing
- ISO-compliant clinical testing
- Regulatory clinical studies
Every project is designed around your device’s intended use, applicable standards, and regulatory objectives.
Supporting Global Regulatory Compliance
Hypoxia Labs works with manufacturers preparing devices for regulatory review in multiple markets. Our testing programs are designed to support submissions to organizations including:
- U.S. Food and Drug Administration (FDA)
- European regulatory authorities (CE)
- National Medical Products Administration (NMPA) of China
Shenzhen University General Hospital became a registered Medical Device Clinical Trial Institution with the NMPA in 2019, providing the qualifications necessary to conduct medical device clinical studies and issue reports recognized by Chinese regulatory authorities. Combined with internationally recognized hypoxia testing methodologies, this partnership enables manufacturers to generate clinical evidence suitable for both domestic and international regulatory submissions.
Clinical Research Experience You Can Trust
Our professionals combine extensive testing expertise, clinical research experience, and regulatory knowledge to help manufacturers move efficiently from product development to market approval.
We support every stage of the product lifecycle, including:
- Clinical study planning
- Protocol development
- Device verification
- Performance validation
- Regulatory compliance
- Final reporting
By working collaboratively with engineering, quality, and regulatory teams, we help manufacturers generate dependable clinical evidence while meeting demanding project timelines.
Our Commitment to Quality and Ethics
At Hypoxia Labs, scientific excellence goes hand in hand with participant safety and ethical research practices. While we are committed to producing accurate, unbiased data that meets domestic and international standards, the safety, confidentiality, comfort, and dignity of every research participant remain our highest priorities.
Our code of conduct includes:
- Protecting the privacy and confidentiality of all study participants
- Maintaining strict restrictions on photography within the laboratory
- Promoting a respectful, professional environment for volunteers and staff
- Prohibiting discriminatory, offensive, or inappropriate behavior
- Ensuring participants receive clear information and answers throughout every study
These principles help ensure every clinical study is conducted with integrity, professionalism, and respect.
Partner With Hypoxia Labs
Whether you’re developing a next-generation pulse oximeter, validating a blood pressure monitoring device, or preparing for FDA, CE, or NMPA regulatory review, Hypoxia Labs provides the clinical expertise and regulatory knowledge to help move your project forward.
Contact our team today to learn how our specialized medical device testing services can support your next innovation.
