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Singapore HSA registration DE0508415

Leltek LELTEK Ultrasound Imaging System

Singapore flagSingapore·CLASS B·LELTEK INC.·Registered August 18, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508415
Registration Date
August 18, 2023
Retention Due Date
August 17, 2025
Product description
The LU700 Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualitied physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. Specific clinical applications and exam types including: LU700C: General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L: General abdominal imaging, small organ (breast, Thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel.
Product Owner
Name
LELTEK INC.
Short Name
LELTEK INC.
Address
6F.-3, No.293, SEC 1, BEIXIN RD., XINDIAN DIST., NEW TAIPEI CITY 23147, TAIWAN
Registrant
Name
V 2 U HEALTHCARE PTE. LTD.
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Importer
Name
V 2 U HEALTHCARE PTE. LTD.
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Model information
Model Name(s)
Leltek Ultrasound Imaging System Leltek Ultrasound Imaging System LELTEK Ultrasound - LeSono (APP)
Model Identifier(s)
LU700C LU700L LeSono
About this record

Access comprehensive regulatory information for Leltek LELTEK Ultrasound Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508415 and owned by LELTEK INC.. The device was registered on August 18, 2023.

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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