Tissue saturation oximeters

Primary DI

06972772850043

Basic UDI-DI Code

697277285001ND

Reference

06972772850043

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Suzhou Engin Bio-medical Electronics Co.,Ltd.

The ECO-N17 series product manufactured by Suzhou Engin Bio-medical Electronics Co., Ltd. is used to monitor blood oxygen parameters of the local tissue, including the tissue oxygen index (TOI), the tissue hemoglobin concentration index (THI), as well as the change of deoxyhemoglobin (Hb) concentration, oxyhemoglobin (HbO2) concentration and total hemoglobin (tHb) concentration in the local tissue compared to their initial values, i.e., ΔCHb, ΔCHbO2 and ΔCtHb. The Tissue Saturation Oximeters controls the alternate emission of three wavelengths of light by LED, measures the emergent light signal after tissue attenuation, and calculates blood oxygen parameters of the tissue through SRS. The product has high sensitivity and stable and reliable performance. The Tissue Saturation Oximeters is a non-invasive device that measures absolute tissue oxygen saturation under the Sensor. The sensor uses three wavelengths to measure light absorption of tissue. It is allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Tissue Saturation Oximeters consists of displayed unit, testing device with communication cable, disposable sensor, battery, power adapter, and power cable. Display unit: The display unit adopts the capacitive touch screen to display the product monitoring interface, provides specifications of four-channel, dual-channel and single-channel, and is equipped with the USB interface, Internet access and serial port, etc. Testing device: The testing unit is used in combination with the display unit, and provides specifications of dual-channel and single-channel. The Tissue Saturation Oximeters achieves its intended use in combination with Tissue saturation oximeter sensors which is non-sterile, single use device.

The Basic UDI-DI associated with this device has 9 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).