Singapore HSA registration DE0507255
Covidien INVOS™ CARESCAPE™* rSO2 - INVOS™ Parameter
Singapore·CLASS C·Covidien IIc·Registered September 13, 2022Device 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 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.
Product Owner
- Name
- Covidien IIc
- 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
About this record
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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