Pure Global

HOYA PENTAX Medical Ultrasound Upper GI Video Scope EG-J10U Series - HSA Registration DE0503268

Access comprehensive regulatory information for HOYA PENTAX Medical Ultrasound Upper GI Video Scope EG-J10U Series in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503268 and owned by Hoya Corporation. The device was registered on June 21, 2019.

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 B
DE0503268
HOYA PENTAX Medical Ultrasound Upper GI Video Scope EG-J10U Series
HSA Registration Number: DE0503268
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The PENTAX Medical Ultrasound Upper GI Video Scope EG - J10U Series (EG34 - J10U/EG38 - J10UT) are intended to provide optical and ultrasound visualization of (via a video monitor), and therapeutic access to the upper gastrointestinal tract including the organs; tissues; and subsystems: esophagus, stomach and duodenum.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0503268
Registration Date
June 21, 2019
Retention Due Date
June 20, 2025
Product Owner
Short Name
Hoya Corporation
Address
6-10-1 Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, JAPAN
Registrant
Address
438A ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-06, SINGAPORE 119967
Importer
Address
438A ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-06, SINGAPORE 119967
Model Information
Model Name(s)
Cleaning Brush Cleaning Brush Cleaning Brush Cleaning Brush PENTAX Medical Ultrasound Upper GI Video Scope EG-J10U Series PENTAX Medical Ultrasound Upper GI Video Scope EG-J10U Series Single Use Balloon Cleaning Adapter PVE Soaking Cap Cleaning Adapter Scanning Unit Connector Soaking Cap O Ring Set Inlet Seal O Ring Set Suction/Balloon Suction Control Valve Air/Water/Balloon Feeding Valve Cleaning Cap for Instrumental Channel Inlet O Ring Set Ventilation Cap Silicone Oil Bite Block Carrying Case
Model Identifier(s)
CS-C12A CS-C13A CS2022A CS5522A EG34-J10U EG38-J10UT OE-A60 OE-B10 OE-C9 OE-G1 OE-U4 OF-B187 OF-B190 OF-B195 OF-B206 OF-B207 OF-B218 OF-B219 OF-C5 OF-Z11 OF-Z5 VE-G25