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Covidien Microstream CO2 - HSA Registration DE0508541

Access comprehensive regulatory information for Covidien Microstream CO2 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508541 and owned by Covidien IIc. The device was registered on October 05, 2023.

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
DE0508541
Covidien Microstream CO2
HSA Registration Number: DE0508541
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Product Description

The GE CARESCAPE™* CO2 - Microstream™ parameter, when connected to the host monitor, is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ or Microstream™ Advance CO2 sampling lines. The GE CARESCAPE™* CO2 - Microstream™ parameter is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508541
Registration Date
October 05, 2023
Retention Due Date
October 04, 2025
Product Owner
Short Name
Covidien IIc
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
Model Information
Model Name(s)
CARESCAPE™ CO2-Microstream™ Parameter
Model Identifier(s)
PMC40M-GE