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Singapore HSA registration DE0508895

SunTech Bravo Mini 24-Hour Ambulatory BP Monitoring System

Singapore flagSingapore·CLASS B·SunTech Medical, Inc.·Registered January 26, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508895
Registration Date
January 26, 2024
Retention Due Date
January 25, 2026
Product description
The Bravo Mini System is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin 4SE, a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (more than 3 years of age) patient’s systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording and display to assist a licensed physician in making a diagnosis.
Product Owner
Name
SunTech Medical, Inc.
Short Name
SunTech Medical, Inc.
Address
5827 South Miami Blvd.,, Suite 100, Morrisville, NC 27560, UNITED STATES
Registrant
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
Model Name(s)
Bravo Mini Model 250D
Model Identifier(s)
99-0233-00
About this record

Access comprehensive regulatory information for SunTech Bravo Mini 24-Hour Ambulatory BP Monitoring System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508895 and owned by SunTech Medical, Inc.. The device was registered on January 26, 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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