XIAMEN ANTS-BRO TECHNOLOGY CO., LTD.

Xiamen ANTS-BRO Technology Co., Ltd. specializes in infrared skin thermometers, including non-contact forehead models for measuring temperature without direct contact. Their product line also includes digital blood pressure monitors with automatic cuff inflation, general-purpose digital thermometers, and pulse oximeters. These devices are designed for both home and clinical use, with some branded products and others sold under generic labels.

The company is headquartered in China. This location influences its regulatory compliance requirements, particularly for devices marketed globally, as it must adhere to both domestic and international medical device regulations.

Devices from Xiamen ANTS-BRO Technology Co., Ltd. are listed in the EU’s EUDAMED registry, the FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone regulatory review processes in the EU and the United States, ensuring transparency and compliance with their respective medical device regulations.

The company’s devices are classified as Class II or Class IIa medical products. This classification is determined by factors like the device’s intended use, risk level, and potential impact on patient safety. Class II devices typically require stricter regulatory controls than Class I but are not as high-risk as Class III devices, which often require premarket approval.