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FUJIFILM CUREVISTA Open / CUREVISTA Apex Digital RF System - HSA Registration DE0507739

Access comprehensive regulatory information for FUJIFILM CUREVISTA Open / CUREVISTA Apex Digital RF 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 DE0507739 and owned by FUJIFILM CORPORATION. The device was registered on February 03, 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
DE0507739
FUJIFILM CUREVISTA Open / CUREVISTA Apex Digital RF System
HSA Registration Number: DE0507739
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Product Description

CUREVISTA Open / CUREVISTA Apex is a remotely operated X-ray radiography and fluoroscopy system that incorporates an FPD (Flat Panel Detector). Its applications are wide and varied, and include diagnosis of conditions affecting the gastrointestinal tract. The R/F table unit serves as a piece of general medical equipment that can be used for diagnosis and treatment.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0507739
Registration Date
February 03, 2023
Change Notification Approval Date
November 05, 2024
Retention Due Date
February 02, 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)
CUREVISTA Apex CUREVISTA Open Diagnostic X-ray high-voltage generator Diagnostic X-ray high-voltage generator DR-V(A) Step Down Transformer TJVR8N85F120-3 Remote control radiogaphic / fluroscopic table X-RAY TUBE ASSEMBLY X-RAY TUBE ASSEMBLY X-RAY TUBE ASSEMBLY X-RAY TUBE ASSEMBLY X-RAY TUBE ASSEMBLY ZT-FT SW ZT-TC-11000 X-ray beam limiting device
Model Identifier(s)
CUREVISTA Apex CUREVISTA Open DHF-158H4 (YA2C-SPF) DHF-158H4 (ZA2C-SPF) DR-V(A) STP DWN TF TJVR8N85F120-3 TU-11000 UH-6FC-31E UH-6GE-31E UH-6PC-31E UH-6QC-307EYB UH-6QC-31EYB ZT-FT SW ZT-TC-11000 ZU-L5TYL