Singapore HSA registration DE0509165
EVIS EUS ENDOSCOPIC Ultrasound Center
Singapore·CLASS B·Olympus Medical Systems Corp.·Registered April 12, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0509165
- Registration Date
- April 12, 2024
- Retention Due Date
- April 11, 2026
Product description
This ultrasound center is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe as indicated within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree and urinary tract. Do not use this device for any purpose other than its intended use.
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)
- EVIS EUS ENDOSCOPIC Ultrasound Center Keyboard CHE Software option ELST Software option SWQ Software option
- Model Identifier(s)
- EU-ME3 MAJ-2380 MAJ-2381 MAJ-2382 MAJ-2383
About this record
Access comprehensive regulatory information for EVIS EUS ENDOSCOPIC Ultrasound Center in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509165 and owned by Olympus Medical Systems Corp.. The device was registered on April 12, 2024.
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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