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GE Voluson Signature Ultrasound Systems - HSA Registration DE0509488

Access comprehensive regulatory information for GE Voluson Signature Ultrasound Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509488 and owned by GE Ultrasound Korea, Ltd.. The device was registered on July 03, 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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CLASS B
DE0509488
GE Voluson Signature Ultrasound Systems
HSA Registration Number: DE0509488
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Product Description

This system is intended for ultrasound evaluation in the following clinical application: Image Acquisition for diagnostic purposes including measurements on acquired images. The device may be used by qualified physicians, sonographers, and healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Clinical applications include: Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Periphervascular, Pediatrics, Cephalic, MSK, Breast and Small part.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509488
Registration Date
July 03, 2024
Retention Due Date
July 02, 2025
Product Owner
Short Name
GE Ultrasound Korea, Ltd.
Address
9, Sunhwan-ro, 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13204, KOREA, REPUBLIC OF
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model Information
Model Name(s)
Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit 11L-D IC5-9-D 9L-D C1-5-D ML6-15-D C2-9-D C1-6-D ECG-USB1 M5Sc-D Biopsy Starter kit RIC5-9-D Needle Guide RAB6-D Biopsy Starter Kit Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Voluson Signature 20 ๏ปฟVoluson Signature 18
Model Identifier(s)
E8385MJ H40432LC H40432LE H40432LJ H40432LN H40442LK H40442LM H40452LE H40452LG H40462LN H40472LT H43262LJ H44901AE H45561FC H48651MS H48681GF H48681MG H48681ML H48691Z H4906BK H4913BA H4913BB Voluson Signature 20 ๏ปฟVoluson Signature 18