Singapore HSA registration DE0504745
Covidien INVOS 7100 Patient Monitoring System
Singapore·CLASS C·Covidien IIc·Registered July 24, 2020Device 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 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.
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
- Name
- COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C