Pure Global AI
HSA · registration DE0507348

Olympus EVIS EXERA III Duodenovideoscope

SingaporeGastroenterology & UrologyClass BOlympus Medical Systems Corp.
Official record identity
Registration number
DE0507348
Model name
Single Use Distal Cover; EVIS EXERA III Duodenovideoscope
Model identifier
MAJ-2315; TJF-Q190V
Registration date
October 05, 2022
Source update date
October 14, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
Published parties
Registrant / registration holder
OLYMPUS SINGAPORE PTE. LTD.
Official description

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Additional source fields
Product owner address
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan
Registrant address
438B ALEXANDRA ROAD, #03-07/12, ALEXANDRA TECHNOPARK, Singapore 119968
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.