Singapore HSA registration DE0503268
HOYA PENTAX Medical Ultrasound Upper GI Video Scope EG-J10U Series
Singapore·CLASS B·Hoya Corporation·Registered June 21, 2019Device 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 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.
Product Owner
- Name
- Hoya Corporation
- 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
About this record
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.
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