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FUJIFILM AMULET SOPHINITY Digital Mammography System - HSA Registration DE0510217

Access comprehensive regulatory information for FUJIFILM AMULET SOPHINITY Digital Mammography 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 DE0510217 and owned by FUJIFILM CORPORATION. The device was registered on January 08, 2025.

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 C
DE0510217
FUJIFILM AMULET SOPHINITY Digital Mammography System
HSA Registration Number: DE0510217
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Product Description

AMULET SOPHINITY is intended for screening and diagnostic mammography. AMULET SOPHINITY is indicated to visualization of breast for the purpose of diagnosis of breast disease.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510217
Registration Date
January 08, 2025
Retention Due Date
January 07, 2026
Product Owner
Short Name
FUJIFILM
Address
26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
FDR-4000AWS FUJIFILM Digital Mammography System
Model Identifier(s)
FDR-4000AWS FDR-4000DRLC