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Covidien Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter - HSA Registration DE0506844

Access comprehensive regulatory information for Covidien Nellcor GE CARESCAPE™* SpO2 – Nellcor 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 DE0506844 and owned by Covidien IIc. The device was registered on May 05, 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
DE0506844
Covidien Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter
HSA Registration Number: DE0506844
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Product Description

The GE CARESCAPE™* SpO2 – Nellcor parameter are indicated for prescription use only for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506844
Registration Date
May 05, 2022
Change Notification Approval Date
September 09, 2024
Retention Due Date
May 04, 2026
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)
Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter
Model Identifier(s)
PMC10GE120N PMC10GE360N