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Singapore HSA registration DE0507962

Masimo NomoLine ISA AX+ Sidestream Gas Analyzer

Singapore flagSingapore·CLASS C·Masimo Corporation·Registered March 30, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0507962
Registration Date
March 30, 2023
Retention Due Date
March 29, 2026
Product description
The ISA AX+ sidestream gas analyzer and accessories including NomoLine sampling lines is intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: • CO2 • N2O • Halothane • Isoflurane • Enflurane • Sevoflurane • Desflurane The ISA AX+ is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. The intended patient population is adult, pediatric, infant and neonatal patients.
Product Owner
Name
Masimo Corporation
Short Name
Masimo Corporation
Address
52 Discovery, Irvine, 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)
NomoLine ISA AX+, DB9 NomoLine ISA AX+, LEMO NomoLine ISA AX+
Model Identifier(s)
4417 4419 9923
About this record

Access comprehensive regulatory information for Masimo NomoLine ISA AX+ Sidestream Gas Analyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507962 and owned by Masimo Corporation. The device was registered on March 30, 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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