Pure Global

SCANMATE FLEX ULTRASOUND DEVICES - HSA Registration DE0509371

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0509371
SCANMATE FLEX ULTRASOUND DEVICES
HSA Registration Number: DE0509371
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 Owner
Short Name
DGH Technology, Inc.
Address
110 Summit Drive, Suite B Exton, PA 19341, Pennsylvania, UNITED STATES
Registrant
Address
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Importer
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