Pure Global
Singapore HSA registration DE0013333

Infinitt Cardiology Picture Archiving Communications System

Singapore flagSingapore·CLASS B·Infinitt Healthcare Co. Ltd·Registered July 09, 2013
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0013333
Registration Date
July 09, 2013
Change Notification Approval Date
August 20, 2024
Retention Due Date
July 08, 2025
Product description
Intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists Cardiology surgeons when doing preoperative planning and postoperative follow-up. Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).
Product Owner
Name
Infinitt Healthcare Co. Ltd
Short Name
Infinitt
Address
12F Daerung Post Tower III 182-4, Guro-dong, Guro-Gu, Seoul, Korea 152-050, KOREA, REPUBLIC OF
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
Model Name(s)
INFINITT Cardiology
Model Identifier(s)
INFINITT Cardiology
About this record

Access comprehensive regulatory information for Infinitt Cardiology Picture Archiving Communications 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 DE0013333 and owned by Infinitt Healthcare Co. Ltd. The device was registered on July 09, 2013.

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