Pure Global
Singapore HSA registration DE0501829

GE Voluson S8/S8t/S10/S10 Expert Ultrasound Systems

Singapore flagSingapore·CLASS B·GE Ultrasound Korea Ltd·Registered July 02, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0501829
Registration Date
July 02, 2018
Change Notification Approval Date
June 26, 2019
Retention Due Date
July 01, 2025
Product description
This system is intended for use by a qualified physician or sonographer for ultrasound evaluation in the following clinical application: Image Acquisition for diagnostic purposes including measurements on acquired image. Clinical applications: • Abdomen • Obstetrics (incl. Fetal Cardio) • Gynecology • Cardiology • Transrectal • Peripher V. • Pediatrics • Cephalic • MSK • Breast • Small parts • Transvaginal
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)
Biopsy Starter Kit (4C-RS) 4C-RS 8C-RS 12L-RS Biopsy Starter Kit (12L-RS) Biopsy Starter Kit (C1-5-RS) Biopsy Starter Kit (ML6015-RS) 9L-RS C1-5-RS ML6-15-RS Voluson S8t BT18 12S-RS Voluson S10 BT18 Voluson S8 BT18 Voluson S10 Expert BT18 3Sc-RS Biopsy Starter Kit (3Sc-RS) Needle Guide (RIC5-9) Needle Guide (RIC5-9) Biopsy Starter Guide (RAB2-6-RS) RAB6-RS IC9-RS Biopsy Starter Kit (IC9-RS) Biopsy Starter Kit (IC9-RS) Needle Guide (RIC5-9) RIC5-9A-RS Needle Guide (IC9-RS) C2-9-RS Biopsy Starter Kit (9L-RS) Biopsy Starter Kit (C2-9-RS)
Model Identifier(s)
E8385NA H4000SR H40402LS H40402LY H40432LC H40432LE H40432LJ H40442LL H40462LA H40462LM H43222LB H44901AB H44942LZ H44952LA H44952LJ H45041DL H46222LC H46721R H48681GF H48681ML H48691LP H48691PJ H48691YW H48691YX H48691Z H48701EJ H48701MN H48701WL H4906BK H4913BA
About this record

Access comprehensive regulatory information for GE Voluson S8/S8t/S10/S10 Expert 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 DE0501829 and owned by GE Ultrasound Korea Ltd. The device was registered on July 02, 2018.

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