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Singapore HSA registration DE0500050

Airon Corporation / MACS CPAP System

Singapore flagSingapore·CLASS B·AIRON CORPORATION·Registered December 17, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0500050
Registration Date
December 17, 2012
Change Notification Approval Date
August 10, 2017
Retention Due Date
December 16, 2025
Product description
"The MACS CPAP System is intended for spontaneously breathing patients requiring up to 140 l/m oxygen at 65% or 100% concentrations. The device is suitable for use in: • Pre-hospital transport applications including accident scene, emergency rescue vehicles • Hospital ICU transport applications including emergency, surgery, post-anesthesia / recovery • Air transport via helicopter or fixed wing"
Product Owner
Name
AIRON CORPORATION
Short Name
AIRON CORPORATION
Address
UNIT 6, 751 NORTH DRIVE, MELBOURNE,, FLORIDA, 32934, UNITED STATES
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model information
Model Name(s)
MACS CPAP SYSTEM Accessories: Accessories: Accessories: Accessories: Accessories:
Model Identifier(s)
20201 PN 21021 PN 21025 PN 21040 PN 21085 PN 58011
About this record

Access comprehensive regulatory information for Airon Corporation / MACS CPAP System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500050 and owned by AIRON CORPORATION. The device was registered on December 17, 2012.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B