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Singapore HSA registration DE0506765

GE Voluson S Series Ultrasound Systems

Singapore flagSingapore·CLASS B·GE Ultrasound Korea, Ltd.·Registered March 30, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506765
Registration Date
March 30, 2022
Retention Due Date
March 29, 2026
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.
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 13204, 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)
8C-RS 12S-RS 3Sc-RS 4C-RS 9L-RS C1-5-RS ML6-15-RS 12L-RS C2-9-RS IC9B-RS Sterile Disposable Endocavity Needle Guide Kits Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Needle Guide Biopsy Starter Guide RAB6-RS IC9-RS Biopsy Starter Kit Biopsy Starter Kit Needle Guide RIC5-9A-RS Biopsy Starter Kit Biopsy Starter Kit Voluson S10 Voluson S10 Expert Voluson S6 Voluson S8 Voluson S8t
Model Identifier(s)
2354973 47237175 47237516 5125386 5212630 5384874 5428942 5499501 5761811 5835938 E8333JB E8385MJ E8385NA H40432LC H40432LE H40432LJ H46222LC H48681GF H48681ML H48691LP H48691PJ H48691YW H48691YX H48691Z H48701EJ H4906BK H4913BA Voluson S10 BT22 Voluson S10 Expert BT22 Voluson S6 BT22 Voluson S8 BT22 Voluson S8t BT22
About this record

Access comprehensive regulatory information for GE Voluson S Series 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 DE0506765 and owned by GE Ultrasound Korea, Ltd.. The device was registered on March 30, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B