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Beijing Rongrui-Century Scie. & Tech. Co., Ltd.

US

Last updated May 23, 2026

What Beijing Rongrui-Century Scie. & Tech. Co., Ltd. makes

The company manufactures pulse oximeter probes designed for both single-use and reusable applications, including reusable finger probes and disposable sensor models for monitoring oxygen saturation and pulse rate. These devices are intended for clinical and home-use settings to provide continuous or intermittent vital sign readings.

The portfolio consists of Class II medical devices, authorised through FDA pathways including the 510(k) and UDI registrations. These products are listed under the FDA’s regulatory framework and are intended for use in the United States.

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 Beijing Rongrui-Century Science & Technology Co., Ltd. manufacture?

The company specialises in pulse oximeter probes, which are used to monitor oxygen saturation (SpO₂) and pulse rate. These include both reusable probes, such as finger probes, and single-use disposable sensors. These devices are designed for clinical and home-use environments to provide vital sign measurements.

Where is Beijing Rongrui-Century Science & Technology Co., Ltd. based?

The company is based in the United States, though its manufacturing operations may be located elsewhere. The devices it produces are authorised for use in the US market under FDA regulatory pathways.

Which regulatory registries or databases list the company’s devices?

The company’s pulse oximeter probes are listed under the FDA’s regulatory frameworks, specifically through the 510(k) premarket notification process and UDI (Unique Device Identification) registrations. These pathways ensure compliance with US medical device regulations.

How are the company’s devices classified under medical device regulations?

The company’s pulse oximeter probes fall under Class II medical device classification, which applies to devices posing moderate risk. This classification requires compliance with specific FDA controls, including performance standards and post-market surveillance, to ensure safety and effectiveness.

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

Information

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US
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Catalogue (6)

DeviceModel / ReferenceRegistriesClassStatus
R-Rui RCT006
FDA UDI
Class IIActive
R-Rui RST063CA
FDA UDI
Class IIActive
R-Rui RSJ091DI
FDA UDI
Class IIActive
R-Rui RCT018
FDA UDI
Class IIActive
R-Rui RSA002DN
FDA UDI
Class IIActive
Pulse Oximeter Sensor (disposable And Reusable) Model Rsa002dn, Rsj002da, Rsj091di, Rst063ca K103685
FDA 510(k)
Class IIActive

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