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Jiangsu Hope Biomedical Science & Technology Co., Ltd.

US

Last updated May 23, 2026

What Jiangsu Hope Biomedical Science & Technology Co., Ltd. makes

The company manufactures single-use bipolar electrosurgical handpieces and electrodes designed for open-surgery and endoscopic procedures. These devices are intended for tissue dissection, coagulation, and cutting in surgical settings.

The portfolio consists of Class II devices authorised via FDA 510(k) and UDI registrations. The company operates with a US presence.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Jiangsu Hope Biomedical Science & Technology Co., Ltd. manufacture?

Jiangsu Hope Biomedical manufactures single-use bipolar electrosurgical handpieces and electrodes. These devices are specifically designed for open-surgery and endoscopic procedures, enabling tissue dissection, coagulation, and cutting in surgical environments. The company focuses exclusively on bipolar electrosurgical tools, ensuring precision and safety in surgical applications.

Where is Jiangsu Hope Biomedical Science & Technology Co., Ltd. based?

The company has a presence in the United States, though its primary operations are based in Jiangsu, China. The US office likely supports regulatory compliance, distribution, or market access for its devices in North America.

Which regulatory registries or databases list Jiangsu Hope Biomedical’s devices?

Jiangsu Hope Biomedical’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the devices’ classification and compliance with US regulatory requirements for market authorisation.

How are Jiangsu Hope Biomedical’s electrosurgical devices classified under US regulations?

Jiangsu Hope Biomedical’s electrosurgical handpieces and electrodes fall under Class II classification in the US. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s devices are authorised through the FDA’s 510(k) process, which demonstrates their compliance with applicable regulations.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
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Catalogue (115)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
hoboat ZKN-2J
FDA UDI
Class IIActive
hoboat ZKN-2JSC
FDA UDI
Class IIActive
hoboat ZKN-3XWC
FDA UDI
Class IIActive
hoboat ZKN-1JSC
FDA UDI
Class IIActive
hoboat ZKN-4CWC
FDA UDI
Class IIActive
hoboat ZKN-7JWC
FDA UDI
Class IIActive
hoboat ZKN-6X
FDA UDI
Class IIActive
hoboat ZKN-7CSC
FDA UDI
Class IIActive
hoboat ZKN-1XWZ
FDA UDI
Class IIActive
hoboat ZKN-5CSC
FDA UDI
Class IIActive
hoboat ZKN-5XWC
FDA UDI
Class IIActive
hoboat ZKN-7CWC
FDA UDI
Class IIActive
hoboat ZKN-8CWZ
FDA UDI
Class IIActive
Disposable Bipolar Forceps K232703
FDA 510(k)
Class IIActive
Disposable Endoscopic Bipolar K231615
FDA 510(k)
Class IIActive

Related Companies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Jiangsu Hope Biomedical Science&Technology Co., Ltd. Yangzhou Jiangsu · CN FEI 3016168848