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FUJIFILM PORTABLE X-RAY UNIT FDR Xair - HSA Registration DE0508437

Access comprehensive regulatory information for FUJIFILM PORTABLE X-RAY UNIT FDR Xair in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508437 and owned by FUJIFILM CORPORATION. The device was registered on August 28, 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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CLASS C
DE0508437
FUJIFILM PORTABLE X-RAY UNIT FDR Xair
HSA Registration Number: DE0508437
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Product Description

The XD2000 is a battery-type portable X-ray system intended for use by qualified physicians and technologists in generating radiographic images of human anatomy, excluding pediatric and neonatal exams. The XD2000 is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508437
Registration Date
August 28, 2023
Change Notification Approval Date
December 04, 2023
Retention Due Date
August 27, 2025
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)
PORTABLE X-RAY UNIT IR Remote Switch
Model Identifier(s)
XD2000 PX XD2000 RS