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Shenzhen Mindray Bio-Medical Electronics BeneVision N Series Patient Monitor - HSA Registration DE0504566

Access comprehensive regulatory information for Shenzhen Mindray Bio-Medical Electronics BeneVision N Series Patient Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504566 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The device was registered on June 08, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0504566
Shenzhen Mindray Bio-Medical Electronics BeneVision N Series Patient Monitor
HSA Registration Number: DE0504566
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Product Description

The BeneVision N series patient monitors (N22, N19, N17, N15, N12), hereafter called the monitor, are intended to be used for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead, and 12-lead selectable, arrhythmia detection, ST segment analysis, QT/QTc monitoring, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), continuous cardiac output (CCO), central venous oxygen saturation (ScvO2), electroencephalograph (EEG), neuromuscular transmission (NMT), and regional oxygen saturation (rSO2). The monitor also provides an interpretation of resting 12-lead ECG.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504566
Registration Date
June 08, 2020
Retention Due Date
June 07, 2025
Product Owner
Short Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Address
Mindray Building,, Keji 12th Road South,, Hi-Tech Industrial Park, Nanshan,, Shenzhen, Guangdong, 518057, CHINA
Registrant
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model Information
Model Name(s)
IBP Truwave Reusable Cable 12 Pin IBP cable 12 Pin IBP cable 12-pin IBP Y cable 12-pin PiCCO cable 12Pin Temperature sensor cable Airway adapter, neonate Flow sensor, 1.8 m, adult & pediatric Flow sensor, 1.8 m, neonatal Flow sensor, 3.3 m, adult & pediatric Flow sensor, 3.3 m, neonatal 12-pin AP&CVP cable Watertrap, DRYLINE II, adult Watertrap, DRYLINE II, neonate ScvO2 optical module Reusable SpO2 sensor, Adt Reusable SpO2 sensor, Adt Reusable SpO2 sensor, Pdt Reusable SpO2 sensor, Pdt Reusable SpO2 sensor, Adu/Ped Reusable SpO2 sensor, Neo Disposable SpO2 sensor, adult Disposable SpO2 sensor, infant Disposable SpO2 sensor, Neonate/Adult Disposable SpO2 sensor, pediatric Disposable SpO2 sensor, adult Disposable SpO2 sensor, infant Disposable SpO2 sensor, Neonate/Adult Disposable SpO2 sensor, pediatric Airway adapter, straight Airway adapter, elbow Gas sampling line, adult 2.5m Gas sampling line, neonate 2.5m AG Module AG Module AG Module AG Module BIS Module BeneLink Module BeneVision N12 Patient Monitor BeneVision N15 Patient Monitor BeneVision N17 Patient Monitor BeneVision N19 Patient Monitor BeneVision N22 Patient Monitor C.O. Module CCO/SvO2 Module Microstream CO2 module Mainstream CO2 module Sidestream CO2 module Sidestream CO2 module EEG Module IBP Module ICG Modle MPM module MPM module MPM module MPM module MPM module MPM module NMT Module PiCCO Module RM Module ScvO2 Module SpO2 Module SpO2 Module Temp Module Tympanic Temp Module rSO2 Module
Model Identifier(s)
0010-21-12179 001C-30-70757 001C-30-70759 040-000815-00 040-000816-00 040-000817-00 040-001187-00 040-001947-00 040-001948-00 040-001949-00 040-001950-00 040-002827-00 100-000080-00 100-000081-00 115-008191-00 512E-30-90390 512F-30-28263 512G-30-90607 512H-30-79061 513A 518B-30-72107 520A 520I 520N 520P 521A 521I 521N 521P 60-14100-00 60-14200-00 60-15200-00 60-15300-00 AG-1 AG-2 AG-3 AG-4 BIS BeneLink BeneVision N12 BeneVision N15 BeneVision N17 BeneVision N19 BeneVision N22 C.O. CCO/SvO2 CO2-1 CO2-2 CO2-3 CO2-4 EEG IBP ICG MPM-1 MPM-13 MPM-14 MPM-3 MPM-7 MPM-9 NMT PiCCO RM ScvO2 SpO2-1 SpO2-2 Temp Tympanic Temp rSO2