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Drรคger Vista 300 Patient monitor - HSA Registration DE0510150

Access comprehensive regulatory information for Drรคger Vista 300 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 DE0510150 and owned by Shanghai Draeger Medical Instrument Co., Ltd. The device was registered on December 17, 2024.

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
DE0510150
Drรคger Vista 300 Patient monitor
HSA Registration Number: DE0510150
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Product Description

The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. Vista 300 Patient Monitor model A monitors physiological parameters: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), anesthetic Gas (AG). Vista 300 Patient Monitor model C monitors physiological parameters: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic Gas (AG), bispectral indexTM (BIS), neuromuscular transmission (NMT). The monitors are not intended for MRI environments.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510150
Registration Date
December 17, 2024
Retention Due Date
December 16, 2025
Product Owner
Short Name
Shanghai Draeger Medical Instrument Co., Ltd
Address
3#, No.229, Hupo Road, Shanghai International Medical Zone, Pudong New Area, 201321, Shanghai, CHINA
Registrant
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Importer
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Model Information
Model Name(s)
Vista 300 sidestream CO2 module Vista 300 Patient Monitor Model A Vista 300 Patient Monitor Model C
Model Identifier(s)
2601068 2601966 2601967