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Olympus Evis Lucera Ultrasound Gastrovideoscope - HSA Registration DE0011345

Access comprehensive regulatory information for Olympus Evis Lucera Ultrasound Gastrovideoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011345 and owned by Olympus Medical Systems Corporation. The device was registered on October 11, 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.

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CLASS B
DE0011345
Olympus Evis Lucera Ultrasound Gastrovideoscope
HSA Registration Number: DE0011345
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Product Description

Designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0011345
Registration Date
October 11, 2012
Change Notification Approval Date
January 18, 2016
Retention Due Date
October 10, 2025
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 Channel cleaning brush EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE Cleaning brush Chain for water-resistant cap Balloon 3 Cleaning adapter for instrument channel port Channel plug Air/water channel cleaning adapter Balloon applicator Biopsy valve Mouthpiece Channel-opening cleaning brush Water-resistant cap Suction cleaning adapter Injection tube Washing tube
Model Identifier(s)
BW-20T BW-7L GF-UCT260 MAJ-1534 MAJ-1739 MAJ-213 MAJ-350 MAJ-621 MAJ-629 MAJ-675 MAJ-853 MB-142 MH-507 MH-553 MH-856 MH-946 MH-974