Pure Global

JPI Healthcare Clear Vision DRE Digital Radiography X-ray System - HSA Registration DE0018633

Access comprehensive regulatory information for JPI Healthcare Clear Vision DRE Digital Radiography X-ray 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 DE0018633 and owned by JPI Healthcare Co., Ltd. The device was registered on October 06, 2016.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0018633
JPI Healthcare Clear Vision DRE Digital Radiography X-ray System
HSA Registration Number: DE0018633
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The system is intended to be used for human in hospital environment under supervision of recommended medical practitioner. The purpose of the system is to acquire X-ray digital images of a patient and show the images to a doctor for diagnosis.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018633
Registration Date
October 06, 2016
Retention Due Date
October 05, 2025
Product Owner
Short Name
JPI Healthcare Co., Ltd
Address
608-ho, 28, Digital-ro 33gil, Guro-ru, 152-769 Seoul, South Korea, KOREA, REPUBLIC OF
Registrant
Address
506 CHAI CHEE LANE, BOXPARK @ CHAI CHEE, #07-02, SINGAPORE 469026
Importer
Address
506 CHAI CHEE LANE, BOXPARK @ CHAI CHEE, #07-02, SINGAPORE 469026
Model Information
Model Name(s)
Bucky stand Bucky table Digital Radiography X-Ray Systems Hand switch X-ray Tube X-ray Tube Software TOSHIBA Xray Flat Panel Imager TOSHIBA Xray Flat Panel Imager TOSHIBA Xray Flat Panel Imager X-ray Tube Hand switch Controller of X-ray generator for Poskom PXR401B High voltage Generator Collimator Collimator Rechargeable Li-ion battery Tube stand High voltage Generator High voltage Generator Software
Model Identifier(s)
BS-M BT-4 CLEAR VISION DRE 140/150 CPI E7239X E7252X ExamVue version 1.0 FDX3543RP FDX3543RPW FDX4343R LUC-8M POSKOM POSKOM CP-401-B POSKOM PXR-401B R302 L/A R302/A SDB-3S1PA TS-M VZW2556RB2-CY VZW2556RE5-xx feel DRCS version 2.0