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Covidien INVOS™ CARESCAPE™* rSO2 - INVOS™ Parameter - HSA Registration DE0507255

Access comprehensive regulatory information for Covidien INVOS™ CARESCAPE™* rSO2 - INVOS™ Parameter in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507255 and owned by Covidien IIc. The device was registered on September 13, 2022.

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
DE0507255
Covidien INVOS™ CARESCAPE™* rSO2 - INVOS™ Parameter
HSA Registration Number: DE0507255
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Product Description

The noninvasive INVOS™ CARESCAPE™* rSO2 – INVOS™ parameter device when connected to the compatible host monitoring system is 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 greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507255
Registration Date
September 13, 2022
Retention Due Date
September 12, 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
Model Information
Model Name(s)
INVOS™ CARESCAPE™* rSO2 - INVOS™ Parameter
Model Identifier(s)
PMC71V-GE