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Singapore HSA registration DE0505066

GE Voluson SWIFT ultrasound systems

Singapore flagSingapore·CLASS B·GE Ultrasound Korea Ltd·Registered October 23, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0505066
Registration Date
October 23, 2020
Retention Due Date
October 22, 2025
Product description
Voluson™ SWIFT / Voluson SWIFT+ are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional for ultrasound imaging, measurement, display and analysis of the human body and fluid. Voluson™ SWIFT / Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson™ SWIFT / Voluson SWIFT+ are intended to be used in a hospital or medical clinic.
Product Owner
Name
GE Ultrasound Korea Ltd
Short Name
Ge Ultrasound Korea Ltd
Address
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
Sterile Disposable Endocavity Needle Guide Kits Needle Guide (IC5-9-D) Biopsy Starter Kit 4C-RS E8C-RS 12L-RS Biopsy Starter Kit (11L-D) Biopsy Starter Kit C1-5-RS ECG -USB1 3Sc-RS Biopsy Starter Kit IC9B-RS Needle Guide Biopsy Starter Kit RAB2-6-RS RAB6-RS IC9-RS Needle Guide Needle Guide Needle Guide RIC5-9A-RS Voluson SWIFT Voluson SWIFT+
Model Identifier(s)
E8333JB E8385MJ E8385NA H4000SR H40402LN H40402LY H40432LC H40432LE H40462LA H43262LJ H45041DL H46222LC H48062AK H48681GF H48681ML H48681WR H48691LP H48691PJ H48691YW H48691YX H48691Z H48701EJ Voluson SWIFT Voluson SWIFT+
About this record

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 DE0505066 and owned by GE Ultrasound Korea Ltd. The device was registered on October 23, 2020.

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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