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Singapore HSA registration DE0005965

Infinitt G3 PACS Picture Archiving and Communications System

Singapore flagSingapore·CLASS C·Infinitt Healthcare Co. Ltd·Registered January 15, 2011
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0005965
Registration Date
January 15, 2011
Change Notification Approval Date
September 11, 2019
Retention Due Date
January 14, 2026
Product description
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
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 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)
INFINITT PACS
Model Identifier(s)
3.0.11.5
About this record

Access comprehensive regulatory information for Infinitt G3 PACS Picture Archiving and Communications System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005965 and owned by Infinitt Healthcare Co. Ltd. The device was registered on January 15, 2011.

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 C