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Olympus EVIS EXERA II Duodenovideoscope - HSA Registration DE0013126

Access comprehensive regulatory information for Olympus EVIS EXERA II Duodenovideoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013126 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
DE0013126
Olympus EVIS EXERA II Duodenovideoscope
HSA Registration Number: DE0013126
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Product Description

This instrument has been designed 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0013126
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 Single Use Soft Brush Auxiliary water tube Mouthpiece Biopsy valve Air/water valve Suction valve Channel-opening cleaning brush Water-resistant cap Channel plug Injection tube AW channel cleaning adapter EVIS EXERA II DUODENOVIDEOSCOPE VIDEOSCOPE
Model Identifier(s)
BW-20T MAJ-1888 MAJ-855 MB-142 MB-358 MH-438 MH-443 MH-507 MH-553 MH-944 MH-946 MH-948 TJF-Q180V