Singapore HSA registration DE0507739
FUJIFILM CUREVISTA Open / CUREVISTA Apex Digital RF System
Singapore·CLASS C·FUJIFILM CORPORATION·Registered February 03, 2023Device 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 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.
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
About this record
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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