Singapore HSA registration DE0506844
Covidien Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter
Singapore·CLASS C·Covidien IIc·Registered May 05, 2022Device 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 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.
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)
- Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter Nellcor GE CARESCAPE™* SpO2 – Nellcor Parameter
- Model Identifier(s)
- PMC10GE120N PMC10GE360N
About this record
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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