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Olympus EVIS EXERA III Duodenovideoscope - HSA Registration DE0507348

Access comprehensive regulatory information for Olympus EVIS EXERA III 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 DE0507348 and owned by Olympus Medical Systems Corp.. The device was registered on October 05, 2022.

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
DE0507348
Olympus EVIS EXERA III Duodenovideoscope
HSA Registration Number: DE0507348
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Product Description

This instrument is intended 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
Registration Information
Registration Number
DE0507348
Registration Date
October 05, 2022
Change Notification Approval Date
April 14, 2025
Retention Due Date
October 04, 2025
Product Owner
Short Name
Olympus
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)
Single Use Distal Cover EVIS EXERA III Duodenovideoscope
Model Identifier(s)
MAJ-2315 TJF-Q190V