Singapore HSA registration DE0504487
Shenzhen Mindray Bio-Medical Electronics BeneVision N1 Patient Monitor
Singapore·CLASS C·Shenzhen Mindray Bio-Medical Electronics Co., Ltd·Registered May 15, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0504487
- Registration Date
- May 15, 2020
- Retention Due Date
- May 14, 2025
Product description
The BeneVision N1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT/QTc Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2), Oxygen (O2), and Continuous Cardiac Output (CCO). The monitor also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: -The CCO is intended for adult and pediatric patients only. The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport with road, rotary and fixed-wing ambulances.
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, 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 cable Adult temperatue probe Adult temperatue probe Pediatric/Neontal temperatue probe Pediatric/Neontal temperatue probe IBP cable IBP cable 12-pin IBP Y cable 12-pin PiCCO cable 12Pin Temperature sensor cable Airway adapter, neonate 12-pin AP&CVP cable Disposable temperature probe Disposable temperature probe, skin Watertrap, DRYLINE II, adult Watertrap, DRYLINE II, neonate PiCCO Module Mainstream CO2 module Microstream CO2 module Sidestream CO2 module Sidestream CO2 module Reusable SpO2 sensor, Adt Reusable SpO2 sensor, Adt Reusable SpO2 sensor, Pdt Reusable SpO2 sensor, Pdt Reusable SpO2 sensor Reusable SpO2 sensor, Neo Reusable SpO2 sensor 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 BeneVision N1 Patient Monitor
- Model Identifier(s)
- 0010-21-12179 0011-30-37392 0011-30-37393 0011-30-37394 0011-30-37395 001C-30-70757 001C-30-70759 040-000815-00 040-000816-00 040-000817-00 040-001187-00 040-002827-00 040-003292-00 040-003293-00 100-000080-00 100-000081-00 115-013198-00 115-013200-00 115-013201-00 115-034095-00 115-037385-00 512E-30-90390 512F-30-28263 512G-30-90607 512H-30-79061 513A 518B-30-72107 518C 520A 520I 520N 520P 521A 521I 521N 521P 60-14100-00 60-14200-00 60-15200-00 60-15300-00 BeneVision N1
About this record
Access comprehensive regulatory information for Shenzhen Mindray Bio-Medical Electronics BeneVision N1 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 DE0504487 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The device was registered on May 15, 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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