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Capnostream 20p - SFDA Registration ME0000000283SFDAA00279

Access comprehensive regulatory information for Capnostream 20p in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000000283SFDAA00279 and manufactured by Covidien llc.

This page provides complete registration details including product category (MD), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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Class IIb
ME0000000283SFDAA00279
Capnostream 20p
SFDA Registration: ME0000000283SFDAA00279
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Product Information

Portable Bedside Monitor

Product Use

intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with 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 in hospitals, hospital-type facilities, and intra-hospital transport environments.

Device Classification
Risk Class
Class IIb
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000000283SFDAA00279
Authorization ID
GHTF-2019-0267
Status
Active
Expire Date
June 30, 2023
Manufacturer
Manufacturer Name
Covidien llc
Model Information
Model ID(s)
CS051COV CS051COV-03
Product Accessories

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