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GE Vivid 7 Pro Diagnostic Ultrasound System - HSA Registration DE0010830

Access comprehensive regulatory information for GE Vivid 7 Pro Diagnostic 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 DE0010830 and owned by GE Vingmed Ultrasound AS. The device was registered on September 12, 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
DE0010830
GE Vivid 7 Pro Diagnostic Ultrasound System
HSA Registration Number: DE0010830
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Product Description

The Vivid 7 ultrasound unit is intended for the following applications: • Abdominal • Fetal/Obstetrics • Pediatric • Small Organ • Adult and Neonatal Cephalic • Cardiac • Peripheral Vascular • Musculo-skeletal • Transesophageal • Transrectal • Transvaginal • Interoperative

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0010830
Registration Date
September 12, 2012
Change Notification Approval Date
September 05, 2016
Retention Due Date
September 11, 2025
Product Owner
Short Name
GE Vingmed Ultrasound
Address
Strandpromenaden 45, N-3183 Horten, NORWAY
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)
ECG-electrodes SilverTRACE ECG Cable Multi-link 3-lead ECG Neonathal (AHA) ECG Cable Multi-link 3-lead ECG Neonathal (IEC) ECG Cable adapter Multi-link 5-lead DIN adapter ECG Cable adapter Multi-link 3-lead DIN adapter ECG-electrodes, snap-type ECG cable with banana-type Sterile TEE Kit w. Latex Cover /X 12U Biopsy starter kit (x5)10L single angle Biopsy starter kit (x5) 3.5C Biopsy starter kit (x5) E8C Biopsy starter kit (x5)12L M4S/M3S/3S Biopsy kit Biopsy bracket 4C Replacement Biopsy supplies Biopsy starter kit (x5) M7C Biopsy starter kit (x5) M12L Biopsy starter kit (x5) 10L multi angle ECG Cables IEC, 412931-002 ECG Leadwires IEC, 412682-003 M4S 5C M7C M12L E8C 10L 12L 8C 9L 5S (ComfortScan) 7S (ComfortScan) Heart Sound Microphone, PCG MA-300 w. Adapter Pulse Preassure Transducer, PCG TY-306 w. adapter EchoPAC 7 EchoStress EchoDICOM TEE RS Probe adapter 6S TEE Clip-On Bite Guard Adult ECG Cable set Q Analysis Tissue Velocity Imaging & Tissue Tracking TEE Clip-On Bite Guard Adult OR 6T 9T TEE Conventional Bite Guard Ped. TEE Conventional Bite Guard Adult Rodent Application DICOM Modality WL DICOM Print Printer, B/W, Sony UP- D897 / UP-D897MD / UP-D897-SYN Printer assembly, Color, UP-D23MD 6T (-RS) Blood Flow Imaging Anatomical M-mode MPEGVue eVue LVO Contrast Advanced Contrast (Research) Footswitch 3 Pedals IP68 ECG cable Marquette IEC,5 leads 9T (-RS) M4S-support & True Speed IMT – Intima Media Thickness Vascular / Abdominal Contrast DVD-Recorder, JVC BD-X201ME TEE RS Probe adapter Vivid 7 Pro console, 19“ LCD mon., 230 Vac Multidim. & Volume Imaging BT08 Volume Ultrasound BT08 Multidimensional Imaging BT08 Multidim. & Volume Imaging BT08 Volume Ultrasound BT08 Multidimensional Imaging BT08 Multidim. & Volume Imaging BT08 Volume Ultrasound BT08 Multidimensional Imaging BT08 Multidim. & Volume Imaging BT08 Volume Ultrasound BT08 Multidimensional Imaging BT08 Vivid 7 Pro console, 17“ LCD mon., 230 Vac 6Tc 6Tc (-RS) 3S (ComfortScan) Pencil 2D / P2D Pencil 6D / P6D Analog VCR PAL, Mitsubishi HS-MD3000E 10S 4C 9L Bio guide starter kit
Model Identifier(s)
2014777-001 412944-001 412944-002 414370-001 414371-001 91920232 E81130HA E83851BC E8385MC E8385MG E8385MJ E8385MM E8385MZ E8385NA E8385RC E8385RF E8385RG E8386RJ E9002ZC E9003CN H4000PA H40412LA H40412LC H40412LD H40412LE H40412LG H40412LH H40412LJ H40412LT H40422LA H40422LB H45001NE H45001NF H45001YS H45001YT H45001YW H45021KP H45021RS H45511EE H45521AL H45521BC H45521BD H45521CB H45521DX H45521DY H45521JG H45521JH H45521PB H45521PD H45521PE H45531HK H45531HL H45531MZ H45531NL H45531NM H45531NP H45531NQ H45531TA H45531TB H45531UD H45531YK H45531YM H45541CU H45541CW H45541EL H45541LF H45541PX H45551LJ H45551LL H45551LM H45551LN H45551LP H45551LR H45551LS H45551LT H45551LW H45551LX H45551LY H45551LZ H45551MA H45551XJ H45551ZD H45551ZE H4701SZ H4830JE H4830JG H4840JG H4901PC H4904PC H4906BK