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GE Voluson Ultrasound System - HSA Registration DE0009516

Access comprehensive regulatory information for GE Voluson 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 DE0009516 and owned by GE Healthcare Austria GmbH & Co OG. The device was registered on August 15, 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
DE0009516
GE Voluson Ultrasound System
HSA Registration Number: DE0009516
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Product Description

The device is intended for use by a qualified physician for ultrasound evaluation of • Fetal/Obstetrics • Abdominal/GYN (including infertility monitoring of follicle development) • Pediatric • Small Organ (breast, testes, thyroid, etc.) • Cardiac (fetal cardio) • 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
90181200
Registration Information
Registration Number
DE0009516
Registration Date
August 15, 2012
Change Notification Approval Date
September 27, 2018
Retention Due Date
August 14, 2025
Product Owner
Short Name
GE Healthcare Austria
Address
Tiefenbach 15, 4871 Zipf, AUSTRIA
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)
Biopsy for IC5-9H, disposable -20 NR- Non Sterile 4C General Purpose Multi Angle Bracket M6C/M7C Biopsy Starter Kit multi-angle 4C-D Curved Array Probe, Abdominal and OB/Gyn Biopsy for IC5-9H, reusable 12L-RS Multi Biopsy Guide C1-5 biopsy guide ML6-15D Biopsy Starter Kit, Multi-Angle M6C Curved Array Probe, Abdominal and OB/Gyn 11L-D linear array probe, small parts IC5-9-D endocavity probe 9L-D linear array probe, small parts & vascular C1-5-D convex Probe ML6-15-D Active Matrix Phased Array Linear Probe C2-9-D C1-6-D M5Sc-D L2-9-D S4-10-D Biopsy Starter Kit (M5Sc-D) 3Sp Multi-angle Biopsy ECG Digital Module RSP Biopsy Starter Kit RAB Biopsy Starter Kit PEC-64; Biopsy for SP PEC71; Biopsy for AB PEC63; Biopsy for RIC (<1.6 mm) PEC69; Biopsy for RRE5-9 (<1,4 mm) - transrectal PEC75; Biopsy for RSP P2D Suprasternal CW-Probe P6D Pencil CW-Probe PEC74; Biopsy for RAB Light PEC76; Biopsy for RNA RAB2-5-D Volume Abdominal Probe RAB4-8-D Volume Abdominal Probe RSP6-16-D; 41441 MHz Realtime 4D broadband linear array probe RIC5-9-D 41403 MHZ 4D ENDOCAVITY PROBE SP10-16-D linear array probe, small parts AB2-7-D 2-7MHz Curved Array Probe, Abdominal & Ob/Gyn RNA5-9-D Volume Microconvex Probe PA6-8-D RRE6-10-D Volume Endocavity Probe RIC6-12 6-12MHz 4D ENDOCAVITY PROBE RAM3-8 4D AMA Abdominal probe RSM5-14 4D AMA Linear Probe Biopsy for RAM, RM6C reusable Biopsy for RSM/RM14L, reuseable Scan/Freeze Footswitch CW - Doppler CW Doppler external BT08/BT09/BT10/BT12 Hardware 3S-D Phased Array Probe PEC83; Biopsy for AB2-7 Upgr VE8 BT08 to VE8 BT09 Upgr VE8 Expert BT08 to VE8 Expert BT09 RRE5-10-D volume Endocavity probe PEC84 biopsy for RRE5-10-D RM6C 4D AMA Abdominal probe Upgr VE8 BT06 to VE8 Expert BT09 Upgrade to new VE6/VE8 BT09 Version RM14L 4D AMA Linear Probe C4-8-D Curved Array Probe 3Sp-D Phased Array Probe Upgr VE6 BT09 to VE6 BT10 Upgr VE8 BT09 to VE8 BT10 Upgr VE8 Exp BT09 to VE8 Exp BT10 Upgr VE6 BT10 to VE8 BT10 Upgr VE8 BT10 to VE8 Exp BT10 Upgrade to new VE6/VE8 BT10 Version Voluson E6 BT12 230V/50HZ Voluson E8 Expert BT12 230V/50HZ Voluson E8 BT12 230V/50HZ Upgrade VE series BT08 to BT12 , includes new monitor Upgrade to new VE6/VE8/VE10 BT12 Version Voluson E6 BT12 115V USA Voluson E6 BT12 100V Japan Voluson E6 BT12 220V Korea Voluson E6 BT12 240V Australia Voluson E6 BT12 220V China Voluson E6 BT12 240V India RAB6-D Volume Abdominal Probe (RAB4-8-UL-D) RAB4/RAB6 Biopsy Strarter Kit (RAB UltraLight Biopsy Starter Kit) Voluson E8 Expert BT12 100V USA Voluson E8 Expert BT12 100V Japan Voluson E8 Expert BT12 220V Korea Voluson E8 Expert BT12 240V Australia Voluson E8 Expert BT12 220V China Voluson E8 Expert BT12 240V India Voluson E8 BT12 115V USA Voluson E8 BT12 100V Japan Voluson E8 BT12 220V Korea Voluson E8 BT12 240V Australia Voluson E8 BT12 220V China Voluson E8 BT12 240V India Upgr VE8Exp BT10 to VE8Exp BT12 Upgr VE6 BT10 to VE6 BT12 Upgr VE6 BT12 to VE8 BT12 Upgr VE8 BT12 to VE8 Exp BT12 Upgr VE8 BT10 to VE8 BT12 Voluson E8 BT13 console Voluson E6 BT13 Console Scan/Freeze Footswitch incl 3 Button USB Upgr VE8 BT13 to VE8 Expert BT13 Upgr VE8 BT12 to VE8 BT13 Upgr VE6 BT13 to VE8 BT13 Upgrade to new VE6/VE8/VE10 BT13 Version ECG Digital Module BT15 Voluson E6 BT15 Voluson E8 BT15 Upgrade to new VE6/VE8 BT15 Version Upgrade new monitor BT10 Voluson E6 BT15 CW Voluson E8 BT15 CW IC9-D Needle Guide Needle Guide Voluson E6 Upgr VE-series BT15 to BT16 Update new VE BT16 SW Voluson E8 CW Doppler VE8 BT16 CW Doppler VE6 BT16 Upgrade VE-Series BT16 to BT17 Update new VE -Series BT17 Software Voluson E8 BT17 Voluson E6 BT17 Upgrade VE-Series BT15 to BT17 IC4-10-D Voluson E8 BT18 Voluson E6 BT18 Upgrade VE-series BT17 to BT18 Update new VE -Series BT18 Software Voluson E6 BT19 Voluson E8 BT19 Voluson E BT19 new SW UPG Voluson E BT 17 to BT19 UPG Voluson E BT 18 to BT19 UPG Biopsy for 9L Biopsy Starter Kit (C2-9-D) Biopsy Starter Kit (C1-6-D)
Model Identifier(s)
E8385MJ E8385NA E8385RF H4001BC H40412LN H40432LC H40432LE H40432LJ H40432LM H40432LN H40442LK H40442LM H40452LE H40452LG H40462LN H40472LT H44901AE H44901AI H45302LA H45561FC H46222LC H46681H H46701AD H46701AE H46721B H46721D H46721R H46721S H46721W H4830JE H4830JG H48621Y H48651DG H48651MN H48651MP H48651MR H48651MS H48651MT H48651MW H48651MY H48651MZ H48651N H48651NA H48651NB H48651NC H48651PN H48651PP H48651T H48661KJ H48661KK H48661LG H48671ME H48671PJ H48671PK H48671WS H48671WT H48671ZG H48671ZH H48681AM H48681AR H48681AS H48681AZ H48681FD H48681FE H48681FF H48681FG H48681FH H48681FL H48681JX H48681JZ H48681KA H48681KP H48681KR H48681KZ H48681LA H48681LB H48681LC H48681LD H48681LE H48681MG H48681ML H48681RD H48681RE H48681RF H48681RG H48681RH H48681RJ H48681RK H48681RL H48681RM H48681RN H48681RP H48681RR H48681RT H48681RU H48681RW H48681RY H48681RZ H48681TS H48681WJ H48681WS H48681XW H48691AJ H48691AK H48691CE H48691LN H48691RL H48691RM H48691RS H48691W H48691XH H48691XJ H48691XM H48691YW H48691YX H48691ZF H48691ZG H48691ZH H48701AY H48701ED H48701EE H48701GW H48701GX H48701JJ H48701KX H48701MS H48701NC H48701WA H48701WB H48701WC H48701WD H48711DA H48711DB H48711DF H48711DW H487711DE H4906BK H4913BA H4913BB