Singapore HSA registration DE0508105
AIRS Medical SwiftMR
Singapore·CLASS B·AIRS Medical Inc.·Registered May 18, 2023Device 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 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.
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
About this record
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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