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GE Vivid i/q Ultrasound system - HSA Registration DE0009509

Access comprehensive regulatory information for GE Vivid i/q 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 DE0009509 and owned by GE Medical Systems Israel. 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
DE0009509
GE Vivid i/q Ultrasound system
HSA Registration Number: DE0009509
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Product Description

The Vivid i / Vivid q ultrasound unit is intended for the following applications: • Abdominal • Cardiac • Musculoskeletal including Superficial • Small Organ • Pediatric • Fetal Heart • Transesophageal • Peripheral Vascular • Neonatal Cephalic • Adult Cephalic • Intraoperative

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0009509
Registration Date
August 15, 2012
Change Notification Approval Date
November 11, 2013
Retention Due Date
August 14, 2025
Product Owner
Short Name
GE Medical Systems
Address
4 Etgar Street, Tirat Carmel 39120, ISRAEL
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
Video Paper UPP110HD Box COLOR PAPER UPC21L SONY e8C Biopsy Kit, single angle, disposable GE M4S/3S Probe Sterile Multi-Angle Biopsy Starter Kit 4C-RS Biopsy Kit 5S-RS 3S - RS 7S - RS 10S -RS 4C-RS e8C-RS 8C-RS 8L-RS i12L-RS 12L-RS 12L-RS Biopsy Kit 9L-RS M4S-RS Foot Switch 12S -RS S-VHS Video Tape Cassette Secondary Scanning Battery Safety Lock Secondary AC Adapter P2D-RS P6D-RS English- UK/HK/Singapore cart support kit SafeLock Cart (220-240V) TEE Probe Interface Module LVO Contrast Ext ECG Cable DICOM Network Connectivity OM Print DICOM Modality Work List MPEGVue eVue Virtual Printer Digital Color Video Printer VCR (PAL) w/ video scan converter VCR (NTSC)w/ video scan converter Video Scan Converter Secondary DVD/CD-RW Portable Deskjet Printer Battery Charger No-spill System Covers (100/pack) Add. shelf Cart S/N <5000 TEE Probe Adaptor for 6T-RS/9T-RS Professional InkJet Printer USB Flash Card MOD 6S-RS Digital b/w Video Printer w/paper HG Wireless Network Interface Roll Pac Vi syst, Must Add an Appl Add. shelf Cart S/N >5000 ICEcord-RS Smart Depth IMT Vascular/Abdominal Contrast B-Flow/BFI Tissue Velocity Imaging and Tissue Tracking TSI (contains TVI/TT) CardioLab Support AFI ICE Probe Interface Module PED ECG ADAPTER EU, LEADS PED ECG ADAPTER US, LEADS RS Probe Holder 3S, 5S, 7S Vi BT10 Cardiac Application Vi BT10 Vasc. Application Vi BT10 Cardiovasc Appl. Vi BT10 Cardiac system Cartosound Interface Vi/q English Upgr BT10 V i/q BT10 UK (240V) Reg Sup & Lang kit LOGIQView Ob measurements P1007MH Isol. VGA Splitter Vi BT10 Vasc.Appl.Upgrade Smart Stress AutoEF ECG w. Respiration Ext. Respiration Adapter USB HDD RAID1 SI/SRI QA OB Application Module Ped. ECG Leads Eu Vi/q Ped. ECG Leads US Vi/q ECG protector Rear bumper PED ECG ADAPTER EU Vi/q PED ECG ADAPTER US Vi/q 3Sc-RS DICOM media Viewer Cartosound interf. W. Video TQ Module Vi Vi BT12 Card sys w.Resp V2 Module Vi S Module Vi CS Module Vi CS Module Vq CQ Module Vq Advanced CQ Module Vq Vi BT12 Cardiac system Vq BT12 Cardiac system 3Sc Biopsy Kit Vq BT12 Vasc.Appl.Upgrade Vi BT12 Vasc.Appl.Upgrade Vq BT12 Card sys w.Resp VI/Q UPGR BT11 TO BT12 EN Vi/q BT12 UK Reg&Lang TEE Clip-On Bite Guard Adult TEE Clip-On Bite Guard Adult OR Adult TEE Scanhead Protection Cover TEE Conventional Bite Guard Pediatric TEE Conventional Bite Guard Adult Bite Hole Indicator 9T - RS Pediatric TEE Scanhead Protection Cover TEE Cleaning and Storing system TEE Storage Rack 6Tc-RS Col Laser Printer 100-120V Col Laser Printer 220-240V 9L-RS Biopsy Kit 8L-RS Biopsy Ki
Model Identifier(s)
E14731GE E70151SA E8385MJ E8385MZ E8385NA H4000PC H4000PD H4000PE H4000PF H4000SR H40402LN H40402LS H40402LT H40402LW H40402LY H40432LC H40442LL H40452LH H41642LS H44901AB H45001PG H45021BB H45021BD H45021BE H45021C H45021CA H45021CP H45021CR H45021D H45021DB H45021DE H45021E H45021EA H45021EB H45021F H45021FA H45021FB H45021FG H45021FH H45021FK H45021FL H45021GA H45021GD H45021HK H45021KE H45021KJ H45021KP H45021NA H45021NF H45021NG H45021RP H45021RY H45021TM H45021TT H45021WP H45021YD H45021YE H45021YF H45021YG H45021YH H45021YJ H45021YK H45021YL H45021YN H45021YQ H45021YR H45031BE H45031BF H45031DS H45031EZ H45031FA H45031FB H45031FD H45031FE H45031GT H45031LM H45031PR H45031RS H45031SD H45031SK H45031SX H45031SY H45031TE H45031TF H45031TJ H45031ZA H45031ZB H45031ZD H45041CY H45041CZ H45041DG H45041DH H45041DJ H45041DK H45041DL H45041DN H45041E H45041EZ H45041F H45041FA H45041FB H45041FC H45041FD H45041FE H45041FF H45041FL H45041FM H45041FX H45041FY H45041FZ H45041G H45041HH H45041KU H45511EE H45521CB H45521CK H45521JG H45521JH H45531HS H45531YM H45541RN H45551NK H45551NM H45551ZE H48681FB H48681FC H4906BK t E8385N