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Olympus EVIS Exera II Colonovideoscope - HSA Registration DE0013124

Access comprehensive regulatory information for Olympus EVIS Exera II Colonovideoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013124 and owned by Olympus Medical Systems Corporation. The device was registered on June 11, 2013.

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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CLASS B
DE0013124
Olympus EVIS Exera II Colonovideoscope
HSA Registration Number: DE0013124
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Product Description

The instruments are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0013124
Registration Date
June 11, 2013
Change Notification Approval Date
June 04, 2024
Retention Due Date
June 10, 2026
Product Owner
Short Name
Olympus Medical Systems
Address
2951 Ishikawa-cho, Hachioji-Shi, Tokyo 192-8507,, JAPAN
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Model Information
Model Name(s)
Channel Cleaning Brush EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE Auxiliary Water Tube Biopsy Valve Air/Water Valve Suction valve Channel -Opening Cleaning Brush Water-Resistant Cap Suction Cleaning Adapter Channel Plug Injection Tube AW Channel Cleaning Adapter EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE EVIS EXERA II COLONOVIDEOSCOPE
Model Identifier(s)
BW-20T CF-H180AI CF-H180AL CF-H180DI CF-H180DL CF-Q180AI CF-Q180AL MAJ-855 MB-358 MH-438 MH-443 MH-507 MH-553 MH-856 MH-944 MH-946 MH-948 PCF-H180AI PCF-H180AL PCF-Q180AI PCF-Q180AL