Singapore HSA registration DE0508437
FUJIFILM PORTABLE X-RAY UNIT FDR Xair
Singapore·CLASS C·FUJIFILM CORPORATION·Registered August 28, 2023Device 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 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.
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
About this record
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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