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Olympus EVIS Exera II Bronchovideoscope - HSA Registration DE0013125

Access comprehensive regulatory information for Olympus EVIS Exera II Bronchovideoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013125 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
DE0013125
Olympus EVIS Exera II Bronchovideoscope
HSA Registration Number: DE0013125
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Product Description

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0013125
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)
EVIS EXERA II BRONCHOVIDEOSCOPE EVIS EXERA II BRONCHOVIDEOSCOPE EVIS EXERA II BRONCHOVIDEOSCOPE Channel Cleaning Brush Single use channel-opening cleaning brush Mouthpiece Single use channel-opening cleaning brush Suction Valve Single-use suction valve Single-use biopsy valve Suction Cleaning Adapter Biopsy Valve Channel -Opening Cleaning Brush
Model Identifier(s)
BF-1T180 BF-P180 BF-Q180 BW-15B BW-201B MA-651 MAJ-1339 MAJ-207 MAJ-209 MAJ-210 MAJ-222 MD-495 MH-507