Wuxi Jiajian Medical Instrument Co., Ltd.

Wuxi Jiajian Medical Instrument Co., Ltd. specializes in producing single-use sterile acupuncture needles, which are commonly used in traditional acupuncture treatments. Additionally, they manufacture electrical probes and conductive pads for peripheral nerve stimulation, as well as devices like acupuncture point detectors. Their product range also includes a migraine-therapy peripheral nerve electrical stimulator, designed to modulate nerves for therapeutic relief. These devices cater to both traditional and modern medical therapies.

The company is based in China. This geographic location influences its regulatory compliance requirements, particularly for devices marketed internationally, where additional authorizations or registrations may be necessary depending on the destination country’s regulatory framework.

Devices from Wuxi Jiajian Medical Instrument Co., Ltd. are listed in the EU’s EUDAMED database, which tracks medical devices authorized within the European Union. They are also included in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking in the United States. These listings help regulatory bodies monitor and verify the devices’ compliance with applicable standards.

The devices produced by Wuxi Jiajian Medical Instrument Co., Ltd. fall into different regulatory classes depending on their intended use and risk level. Most of their products are classified as Class II or Class IIa, which typically require additional scrutiny, such as clinical evaluations or specific manufacturing controls, due to their moderate to higher risk. Some devices may also be classified as unclassified (U), indicating they are exempt from strict regulatory classification under certain frameworks, often due to minimal risk or well-established safety profiles.