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Covidien Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor - HSA Registration DE0507227

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.

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CLASS C
DE0507227
Covidien Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor
HSA Registration Number: DE0507227
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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.

Device 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 Owner
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
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