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AIRS Medical SwiftMR - HSA Registration DE0508105

Access comprehensive regulatory information for AIRS Medical SwiftMR in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508105 and owned by AIRS Medical Inc.. The device was registered on May 18, 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 B
DE0508105
AIRS Medical SwiftMR
HSA Registration Number: DE0508105
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Product Description

SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508105
Registration Date
May 18, 2023
Change Notification Approval Date
November 19, 2024
Retention Due Date
May 17, 2026
Product Owner
Short Name
AIRS Medical Inc.
Address
13-14F, Keungil Tower, 223, Teheran-ro, Gangnam-gu, Seoul, 06142, KOREA, REPUBLIC OF
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model Information
Model Name(s)
SwiftMR SwiftMR
Model Identifier(s)
A20-CL A22-OP