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Singapore HSA registration DE0503283

HOYA PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR

Singapore flagSingapore·CLASS B·Hoya Corporation·Registered June 25, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0503283
Registration Date
June 25, 2019
Retention Due Date
June 24, 2025
Product description
The PENTAX Medical Ultrasound Upper GI Video Scope (EG36 - J10UR) is intended to provide optical and ultrasound visualization of (via video monitor), and therapeutic access to the upper gastrointestinal tract including the organs; tissues; and subsystems: esophagus, stomach and duodenum.
Product Owner
Name
Hoya Corporation
Short Name
Hoya Corporation
Address
6-10-1 Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, JAPAN
Registrant
Name
PENTAX MEDICAL SINGAPORE PTE. LTD.
Address
438A ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-06, SINGAPORE 119967
Importer
Name
PENTAX MEDICAL SINGAPORE PTE. LTD.
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 EG36-J10UR 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 EG36-J10UR OE-A51 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
About this record

Access comprehensive regulatory information for HOYA PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503283 and owned by Hoya Corporation. The device was registered on June 25, 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 DatabasePowered by Pure Global AIHSA Official DataCLASS B