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Singapore HSA registration DE0509412

Hoya PENTAX Medical Video Duodenoscope

Singapore flagSingapore·CLASS B·Hoya Corporation·Registered June 19, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0509412
Registration Date
June 19, 2024
Retention Due Date
June 18, 2025
Product description
The PENTAX Medical Video Duodenoscope is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
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)
PENTAX Medical Video Duodenoscope PENTAX Medical Video Duodenoscope Reusable, Distal Rubber Tip Pentax Medical Single Use, Sterile Distal End Cap with Elevator
Model Identifier(s)
ED34-i10cT ED34-i10cT2 OE-A55 OE-A63
About this record

Access comprehensive regulatory information for Hoya PENTAX Medical Video Duodenoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509412 and owned by Hoya Corporation. The device was registered on June 19, 2024.

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