Singapore HSA registration DE0509371
SCANMATE FLEX ULTRASOUND DEVICES
Singapore·CLASS B·DGH Technology, Inc.·Registered June 10, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0509371
- Registration Date
- June 10, 2024
- Retention Due Date
- June 09, 2025
Product description
The Scanmate Flex is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
Product Owner
- Short Name
- DGH Technology, Inc.
- Address
- 110 Summit Drive, Suite B Exton, PA 19341, Pennsylvania, UNITED STATES
Registrant
- Name
- VITOP PTE.LTD.
- Address
- 15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Importer
- Name
- VITOP PTE.LTD.
- Address
- 15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Model information
- Model Name(s)
- UBM Probe 35 MHz Transducer 50 MHz Transducer 12 MHz B-Scan Probe 20 MHz B-Scan Probe Scanmate Flex
- Model Identifier(s)
- DGH1500 DGH1500-35 DGH1500-50 DGH1912 DGH1920 FLEX
About this record
Access comprehensive regulatory information for SCANMATE FLEX ULTRASOUND DEVICES in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509371 and owned by DGH Technology, Inc.. The device was registered on June 10, 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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