At VistaMed Technologies (Pioneering Advanced Medical Solutions for Global Healthcare), patient safety and clinical accuracy are the foundations of our engineering. Founded in 2009, we adhere to the most rigorous international regulatory frameworks. All our chronic disease monitoring devices are manufactured in an ISO 13485-certified facility and comply with global market authorization requirements.
Corporate Quality Management Systems
Our manufacturing and organizational processes are strictly audited by leading international regulatory bodies.
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ISO 13485:2016 Quality Management System
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Scope: Design, manufacture, and distribution of medical devices.
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Certificate Number: BSI Certificate No. FS 738429
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Certifying Body: BSI (British Standards Institution)
- 🔍 How to Verify: Visit the official BSI Client Directory (A-Level Source) and search our certificate number to verify our active status.
Global Market Authorizations & Clearances
We maintain active market clearances in key global regions, ensuring our products meet local legal and clinical requirements.
United States FDA 510(k) Clearance
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Authorization: Cleared for U.S. market distribution.
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Reference: K243456 (IntelliScan AI Diagnostic System & Related Monitoring Devices)
- 🔍 Official Verification: Verify directly on the U.S. Food and Drug Administration (FDA) official database: FDA 510(k) Premarket Notification Database (Search "K243456" or "VistaMed").
European Union CE MDR Certification
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Compliance: Fully compliant with EU Medical Device Regulation (MDR) 2017/745.
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Notified Body: TÜV SÜD (NB 0123)
- 🔍 Official Verification: TÜV SÜD is a designated Notified Body listed on the European Commission's NANDO Database.
NMPA Registration (China)
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Authorization: Class III Medical Device Registration
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Certificate Number: No. 20253060089
Product-Specific Clinical Standards
Our chronic disease monitoring portfolio is rigorously tested against specific international clinical protocols. (All clinical data and performance metrics align strictly with our registered certificates).
| Product Category |
Core Products Covered |
Applied Clinical Standards & Validation |
| Blood Pressure Monitors |
Arm BP Monitor, Wrist BP Monitor, LED BP Monitor, Smart BP Monitor |
• ISO 81060-2 Validation: Meets international accuracy standards.
• AAMI/ESH/ISO Protocol: Validated through internationally recognized clinical protocols. |
| Blood Glucose Monitors |
Blood Glucose Monitor & Test Strips |
• ISO 15197:2013 Compliance: Adheres strictly to in vitro diagnostic test system requirements for glucose monitoring. |
| Oximetry & Temperature |
Fingertip Pulse Oximeter, Rigid/Flexible/Body/Smart Thermometers |
• GB 9706.1-2020: National standard compliance for electrical safety.
• IEC 62304: Medical device software lifecycle certification. |
| ECG Monitors |
ECG Monitor (Single/Multi-lead) |
• Compliant with relevant IEC/ISO clinical standards for electrocardiographic devices. |
Data Security & Patient Privacy Protection
As digital health innovators, VistaMed Technologies prioritizes data security. We do not directly collect personal health information (PHI) via our corporate website.
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HIPAA & GDPR Compliant: Our data processing systems are certified to meet the Health Insurance Portability and Accountability Act (USA) and General Data Protection Regulation (EU).
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Infrastructure Security: In strict adherence to data protection laws, our public website servers are physically and logically isolated from any patient data systems or diagnostic networks.
Industry Recognitions & R&D Excellence
Our commitment to advancing medical technology is supported by global institutions and peer-reviewed research.
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Patents & Research: Holder of 87 Granted Patents (52 Domestic, 35 International). Supported by the National Key R&D Program and EU Horizon Europe Research Partnership Grant (2023-2026).
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Academic Validation: 12 Peer-Reviewed Publications in High-Impact Medical Journals (2022-2024). (Full bibliography available upon official request).
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Industry Awards:
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Frost & Sullivan 2024 Asia-Pacific Medical Imaging Innovation Award.
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MedTech Breakthrough Award: AI Diagnostic Solution (2024).
Document Downloads & Technical Resources
Healthcare professionals, procurement officers, and authorized distributors can access full regulatory documentation below.
⚖️Medical Disclaimer:
The information provided on this website is for informational purposes only and is intended for healthcare professionals, hospital procurement departments, and authorized distributors.
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Registered Scope: All product descriptions, specifications, and applications align strictly with the contents approved by relevant regulatory authorities (e.g., FDA, NMPA, EMA).
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Clinical Use: Devices should only be used according to their approved Instructions for Use (IFU). We make no unverified claims regarding clinical outcomes or disease cures.
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Professional Guidance: The medical devices listed, including remote monitoring and diagnostic equipment, are designed to assist healthcare professionals. They are not intended to replace professional medical advice, diagnosis, or treatment. Certain advanced equipment is restricted to professional healthcare facility use only.
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Data Privacy: VistaMed Technologies complies fully with the Personal Information Protection Law. We do not collect direct patient health data through this marketing website.
Sources of regulatory standards referenced on this site adhere to guidelines from the U.S. FDA, the World Health Organization (WHO), and the International Organization for Standardization (ISO).
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