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Singapore HSA registration DE0011729

Olympus EVIS Small Intestinal Videoscope

Singapore flagSingapore·CLASS B·Olympus Medical Systems Corporation·Registered December 06, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration information
Registration Number
DE0011729
Registration Date
December 06, 2012
Change Notification Approval Date
June 04, 2024
Retention Due Date
December 05, 2025
Product description
This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion.
Product Owner
Name
Olympus Medical Systems Corporation
Short Name
Olympus Medical Systems
Address
2951 Ishikawa-cho, Hachioji-Shi, Tokyo 192-8507,, JAPAN
Registrant
Name
OLYMPUS SINGAPORE PTE LTD
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Importer
Name
OLYMPUS SINGAPORE PTE LTD
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Model information
Model Name(s)
BALLON CONTROL UNIT EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SINGLE USE SPLINTING TUBE ENDOSCOPIC CO2 REGULATION UNIT
Model Identifier(s)
OBCU SIF-Q180 SIF-Q260 ST-SB1 UCR
About this record

Access comprehensive regulatory information for Olympus EVIS Small Intestinal Videoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011729 and owned by Olympus Medical Systems Corporation. The device was registered on December 06, 2012.

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