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Infinitt Healthcare Infinitt ULite - HSA Registration DE0507267

Access comprehensive regulatory information for Infinitt Healthcare Infinitt ULite in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507267 and owned by Infinitt Healthcare Co. Ltd. The device was registered on September 16, 2022.

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
DE0507267
Infinitt Healthcare Infinitt ULite
HSA Registration Number: DE0507267
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Product Description

INFINITT ULite is a device that displays medical images (including mammogram) and data from various imaging sources.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0507267
Registration Date
September 16, 2022
Retention Due Date
September 15, 2025
Product Owner
Short Name
Infinitt
Address
12F Daerung Post Tower III 182-4, Guro-dong, Guro-Gu, Seoul, Korea 152-050, KOREA, REPUBLIC OF
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
INFINITT ULite
Model Identifier(s)
801