SingGao Precision Technology (Dongguan) Co., Ltd

SingGao Precision Technology (Dongguan) Co., Ltd specializes in gas volume reference standards, such as the AES model. These devices are designed for calibrating and verifying gas measurement instruments, ensuring accuracy in applications like medical gas flow testing or industrial gas analysis.

The company is based in the United States, though its name includes ‘Dongguan,’ which may reference its manufacturing origins in China. The regulatory and commercial operations are conducted from its US presence.

Yes, SingGao’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices like the AES gas volume reference standard, ensuring traceability and compliance with US regulatory requirements.

SingGao’s devices fall under Class I classification in regulatory frameworks. This classification applies to products posing minimal risk, such as gas volume reference standards, which are generally considered safe and effective for their intended use without requiring stringent pre-market approval.