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GE Voluson SWIFT ultrasound systems - HSA Registration DE0510129

Access comprehensive regulatory information for GE Voluson SWIFT 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 DE0510129 and owned by GE Ultrasound Korea, Ltd.. The device was registered on December 11, 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
DE0510129
GE Voluson SWIFT ultrasound systems
HSA Registration Number: DE0510129
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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, Peripher vascular, Pediatrics, Cephalic, MSK, Breast and Small part.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510129
Registration Date
December 11, 2024
Retention Due Date
December 10, 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)
12S-RS 3Sc-RS 4C-RS 12L-RS 9L-RS C1-5-RS IC9B-RS Needle Guide Biopsy Starter Kit ECG -USB1 Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Needle Guide Biopsy Starter Kit RAB2-6-RS RAB6-RS IC9-RS Needle Guide Needle Guide Needle Guide RIC5-9A-RS Biopsy Starter Kit Voluson SWIFT Voluson SWIFT+
Model Identifier(s)
47237175 47237516 5125386 5141337 5212630 5384874 5835938 E8385MJ E8385NA ECG -USB1-EX H40432LC H40432LE H46222LC H48681GF H48681ML H48681WR H48691LP H48691PJ H48691YW H48691YX H48691Z H48701EJ H4906BK Voluson SWIFT Voluson SWIFT+