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GE VOLUSON® S Series Ultrasound System - HSA Registration DE0009475

Access comprehensive regulatory information for GE VOLUSON® S Series Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009475 and owned by GE Ultrasound Korea, Ltd. The device was registered on August 13, 2012.

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
DE0009475
GE VOLUSON® S Series Ultrasound System
HSA Registration Number: DE0009475
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Product Description

The system is intended for use by a qualified physician for ultrasound evaluation in the following clinical applications:• Fetal/Obstetrics • Abdominal (includingrenal and GYN/pelvic) • Pediatric • Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients) •Neonatal Cephalic • Adult Cephalic •Cardiac (Adult and Pediatric) • Peripheral Vascular • Musculo-skeletal Conventional and • Superficial • Transvaginal and Transrectal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181300
Registration Information
Registration Number
DE0009475
Registration Date
August 13, 2012
Change Notification Approval Date
September 06, 2016
Retention Due Date
August 12, 2025
Product Owner
Short Name
GE Ultrasound Korea, Ltd
Address
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
BIOPSY FOR E8C, DISPOSABLE BIOPSY FOR IC5-9H/E8C, DISPOSABLE (20) 4C BIOPSY STARTER KIT 4C-RS E8C-RS 8C-RS 12L-RS BIOPSY FOR IC5-9H/E8C, REUSABLE 12L Biopsy Kit 9L-RS C1-5-RS ML6-15-RS B&W Printer Digital (SONY, UP-D897) Color Printer Digital (SONY, UP-D25MD) VOLUSON S8 BT16 VOLUSON S8_Pro BT16 VOLUSON S6 BT16 12S-RS AB 2-7RS RAB4-8-RS 3Sc-RS ECG Cable - AHA ECG cable - IEC Connection Module Report Data CWD Opt. Kit for VS6 BT12/BT14 CWD Opt. Kit for VS8 BT12/BT14 PEC78; Biopsy for RAB RAB2-5-RS Voluson S6/S8 Destination Kits PEC71 ; Biopsy for AB2-7 PEC63; Biopsy for RIC5-9 (<1.6 mm) Hardware Option USB FootSwitch - 3 Buttons High Cabinet Drawer Horizontal TV Holder Vertical TV Holder VOLUSON S6 - APAC VOLUSON S8 - APAC UPKIT1 (128 Channel Upgrade) UPKIT3 (S6 to S8 Upgrade) Printer installation kit (BW and Color) DVR Module CWD UPKIT for VS6 BT12/BT14 CWD UPKIT for VS8 BT12/BT14 ECG Option Kit UPKIT1 wi CW (128 Channel Upgrade) UPKIT3 wi CW (S6 to S8 Upgrade ) BT14 Voluson S6 BT14 Voluson S6 - Premium BT14 Voluson S6 - High BT14 Voluson S8 BT14 Voluson S8 - High BT14 Voluson S8 Pro BT14 Voluson S8 – HDLive UVC INSTALLATION KIT VOLUSON S6_S8 BT14 SW UPKIT for VS6 BT14 SW UPKIT for VS8 CPS with Battery Pack HDlive Full Set For S8 (for IB) HDlive Full Set For S6 (for IB) HDlive Full Set For S8 (for MC) HDlive Full Set For S6 (for MC) BT14 Voluson S6 – HDLive HDlive HDlive for MC only P2D PEC74; Biopsy for RAB RIC5-9W RS Bluetooth Line Printer EU+USA Printers PEC83; Biopsy for AB2-7 Isolation Transformer RAB2-6-RS 4DView PC Software RAB6-RS IC9-RS RIC5-9A-RS
Model Identifier(s)
E8333JB E8385MJ E8385NA H4000SR H40402LN H40402LS H40402LY H40412LN H40432LC H40442LL H40462LA H40462LM H44492LB H44642LW H44792LY H44792LZ H44802LA H44901AB H44901AD H45021L H45041DL H45302LY H45302LZ H46681S H46692LY H46692LZ H46701AE H46701NA H46712LM H46721D H46721R H46732LD H46732LF H46732LG H46732LH H46732LJ H46732LK H46732LZ H46752LZ H46762LP H46762LR H46762LS H46772LJ H46802LA H46802LB H46802LC H46822LT H46822LW H46902LN H46902LP H46902LR H46902LS H46902LT H46902LW H46902LZ H46942LW H46962LW H46962LY H46972LM H46982LA H46982LB H46982LC H46982LD H46982LR H46982LT H46982LW H4830JE H48621Y H48661EF H48661MT H48661MW H48671ME H48671WN H48681WR H48691KL H48691LP H48691PJ H48701EJ