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Singapore HSA registration DE0509835

Masimo SedLine Sedation Monitor

Singapore flagSingapore·CLASS C·Masimo Corporation·Registered September 24, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0509835
Registration Date
September 24, 2024
Retention Due Date
September 23, 2025
Product description
The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
Product Owner
Name
Masimo Corporation
Short Name
Masimo Corporation
Address
52 Discovery, CA 92618, UNITED STATES
Registrant
Name
MASIMO ASIA PACIFIC PTE. LTD.
Address
31 UBI ROAD 1, #04-05, SINGAPORE 408694
Importer
Name
MASIMO ASIA PACIFIC PTE. LTD.
Address
31 UBI ROAD 1, #04-05, SINGAPORE 408694
Model information
Model Name(s)
SedLine EEG Sensor SedLine Patient cable RD SedLine EEG Sensor, Adult RD SedLine Patient Cable SedLine Module
Model Identifier(s)
2479 3637 4248 4298 4497
About this record

Access comprehensive regulatory information for Masimo SedLine Sedation Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509835 and owned by Masimo Corporation. The device was registered on September 24, 2024.

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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