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Covidien INVOS 7100 Patient Monitoring System - HSA Registration DE0504745

Access comprehensive regulatory information for Covidien INVOS 7100 Patient Monitoring System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504745 and owned by Covidien IIc. The device was registered on July 24, 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
DE0504745
Covidien INVOS 7100 Patient Monitoring System
HSA Registration Number: DE0504745
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Product Description

The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals >2.5 kg at risk for reduced-flow or no-flow ischemic states. For patients ≤2.5 kg, the INVOS™ Patient Monitor, model PM7100 is only intended for adjunct trend monitoring of regional hemoglobin oxygen saturation of blood tissue beneath the sensor. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood tissue beneath the sensor in any individual.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504745
Registration Date
July 24, 2020
Change Notification Approval Date
March 05, 2025
Retention Due Date
July 23, 2025
Product Owner
Short Name
Covidien IIc
Address
15 Hampshire Street, Mansfield, MA02048, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
INVOS™ Infant Regional Saturation Sensor INVOS™ PM7100 Patient Monitor INVOS™ Preamplifier INVOS™ Adult rSO2 Sensor INVOS™ Adult rSO2 Sensor INVOS™ Adult rSO2 Sensor INVOS™ Adult rSO2 Sensor INVOS™ Pediatric rSO2 Sensor INVOS™ Pediatric rSO2 Sensor INVOS™ Pediatric rSO2 Sensor INVOS™ Pediatric rSO2 Sensor
Model Identifier(s)
CNN/SNN PM7100 PMPAMP71 PMSENS71-A-10 PMSENS71-A-20 PMSENS71-A-280 PMSENS71-A-5 PMSENS71-P PMSENS71-P-10 PMSENS71-P-20 PMSENS71-P-5