Singapore HSA registration DE0507227
Covidien Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor
Singapore·CLASS C·Covidien llc·Registered September 01, 2022Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507227
- Registration Date
- September 01, 2022
- Change Notification Approval Date
- April 07, 2025
- Retention Due Date
- August 31, 2025
Product description
The Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor is intended for use in non-invasive continuous or spot-check monitoring of functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate for neonates and infants weighing less than 3 kg or adults and pediatrics weighing more than 40 kg. It is indicated for use during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra- hospital transport, mobile emergency medical applications including both ground and air transport and home environments.
Product Owner
- Name
- Covidien llc
- Short Name
- Covidien llc
- Address
- 15 Hampshire Street Mansfield, MA 02048, 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)
- Nellcor™ OxySoft™ Neonatal-Adult SpO2 Nellcor™ OxySoft™ Neonatal-Adult SpO2
- Model Identifier(s)
- OxySoftN OxySoftNHC
About this record
Access comprehensive regulatory information for Covidien Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507227 and owned by Covidien llc. The device was registered on September 01, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C