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Singapore HSA registration DE0500250

Tomey Ultrasonic B Scanner UD-8000

Singapore flagSingapore·CLASS B·Tomey Corporation·Registered September 16, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
HSA Product Code
HSAMDB00108
HS Code
90185000
Registration information
Registration Number
DE0500250
Registration Date
September 16, 2014
Change Notification Approval Date
May 06, 2016
Retention Due Date
September 15, 2025
Product description
A diagnostic ultrasound imaging system designed exclusively for use in ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. This device will generate ultrasound pulse, direct them to a target area, detect the resulting ultrasound echoes and process the resulting information producing/displaying static of dynamic 2- or 3-dimensional images.
Product Owner
Name
Tomey Corporation
Short Name
Tomey Corporation
Address
2-11-33 Noritakeshinmachi Nishi-Ku, Nagoya 451 - 0051, JAPAN
Registrant
Name
NING KWONG OPTICAL COMPANY (PRIVATE) LIMITED
Address
51 CHIN SWEE ROAD, SINGAPORE 160051
Importer
Name
NING KWONG OPTICAL COMPANY (PRIVATE) LIMITED
Address
51 CHIN SWEE ROAD, #02-95/99, SINGAPORE 160051
Model information
Model Name(s)
Ultrasound gel Non-Sterile Biometry Probe Non-Sterile Pachymeter Probe Tomey Ultrasonic A/B Scanner with Pachymeter Tomey Ultrasonic B Scanner Non-Sterile Probe Non-Sterile B-Scan Probe Non-Sterile A Scan Probe Non-Sterile UBM Probe CD Rom CD Rom
Model Identifier(s)
03-08 AL-2010 AL-2020 UD-800 UD-8000 UD-8010 UD-810 UD-820 UD-840 Version 6R Version 7E
About this record

Access comprehensive regulatory information for Tomey Ultrasonic B Scanner UD-8000 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500250 and owned by Tomey Corporation. The device was registered on September 16, 2014.

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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