Shenzhen Anke High-Tech Co., Ltd.

Shenzhen Anke High-Tech Co., Ltd. specializes in medical imaging devices, including intraoral digital imaging sensors for dental applications and full-body MRI systems with permanent magnets. Their portfolio also covers X-ray computed tomography systems, digital radiography systems, and digital mammography systems, all designed for diagnostic imaging in healthcare settings.

The company is headquartered in Shenzhen, China. While the location does not inherently determine regulatory classification or approval status, it influences the manufacturer’s compliance pathways for global markets, including adherence to regional standards like those in the EU and the U.S. This also means their devices must meet the specific requirements of jurisdictions where they are marketed, such as the EU MDR or FDA regulations.

Devices from Shenzhen Anke High-Tech Co., Ltd. are listed in the EUDAMED database (for EU compliance), the FDA’s 510(k) premarket notification registry (for U.S. clearance), and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices across jurisdictions, helping regulators and healthcare providers verify device details, classifications, and compliance statuses.

The company’s devices are classified under EU Medical Device Regulations as Class II, IIa, or IIb. This classification determines the level of scrutiny and risk assessment required during the authorization process. For example, Class IIb devices pose a higher risk than Class IIa and require additional evidence of safety and performance, such as clinical data or specialized conformity assessments, to ensure patient safety and regulatory compliance.

Checking a device’s listing in the FDA’s 510(k) or UDI systems helps verify its legal status in the U.S. market, ensuring it has undergone the necessary premarket review (for 510(k)) or carries a valid UDI for tracking and traceability. This is critical for confirming compliance with U.S. regulations, identifying potential recalls, and ensuring the device meets safety and performance standards before use in clinical settings.