Pure Global

GE Vivid E9 Ultrasound System - HSA Registration DE0009508

Access comprehensive regulatory information for GE Vivid E9 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 DE0009508 and owned by GE Vingmed Ultrasound AS. 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0009508
GE Vivid E9 Ultrasound System
HSA Registration Number: DE0009508
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The ultrasound unit is intended for the following applications: • Abdominal • Fetal/Obstetrics • Pediatric • Small Organ • Adult and Neonatal Cephalic • Cardiac • Peripheral Vascular • Musculoskeletal • Transesophageal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0009508
Registration Date
August 15, 2012
Change Notification Approval Date
March 10, 2015
Retention Due Date
August 14, 2025
Product Owner
Short Name
GE Vingmed
Address
Strandpromenaden 45, N-3183 Horten, NORWAY
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)
iC5-9-D Needle guide Biopsy bracket 4C Multiangle replacement kit (x24) 4C-D 4V-D 8C 12L-RS Multi Biopsy Guide (for 11L-D) C1-5-D Biopsy Bracket ML6-15-D Biopsy Starter Kit , Multi-Angle 11L-D IC5-9-D 9L-D C1-5-D ML6-15-D C2-9-D M5Sc-D 6S-D 12S-D TEE Clip-On Bite Guard Adult i13L TEE Clip-On Bite Guard Adult OR TEE Scanhead Protection Cover 6T 9T TEE Conventional Bite Guard Ped. TEE Conventional Bite Guard Adult B&W printer, digital with USB 6T-RS 9T-RS Color Laser Printer 220V Installation for printers TEE Probe Aadapter -RS [6] Ped TEE Scanhead Protection Cover Vivid E9, 100-230VAC CLIP-ON BITE GUARD, 25PCS CLIP-ON BITE GUARD OR, 25PCS BITE GUARD PEDIATRIC, 25PCS BITE GUARD ADULT, 25PCS SCANHEAD PROTECTION, ADULT, 25PCS SCANHEAD PROTECTION, PEDIATRIC, 25PCS M5S-D TEE Cleaning and Storing System TEE Bed stand TEE Storage rack 6Tc 6Tc-RS Color Video Printer M5S Biopsy Kit (M5S-D / M5Sc-D Biposy kit) Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC AFI - Productivity package IMT - Intima Media thickness LVO Contrast Imaging Vascular Contrast LV Mass Only 4D Strain and LV Mass Stress Auto 2D EF Rodent Advanced QScan Imaging Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC 6VT-D TEE Interface Module Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC Vivid E9, 100-230VAC TomTec 4D MV - Assessment Vivid E9, 100-230VAC ECG cable, adult, AHA ECG lead set, adult, AHA ECG cable, adult, IEC ECG lead set, adult, IEC ECG cable, neo, AHA ECG cable, neo, IEC Lead/electr neo AHA 600 Lead/electr neo IEC 600 Adapter, ECG 3-lead 6VT-D 4D TEE probe P2D P6D 9L Bio guide starter kit C2-9-D Bipsy Bracket
Model Identifier(s)
E8385MJ E8385NA E8385RC H4001BC H4001BT H40412LJ H40432LC H40432LE H40432LJ H40432LN H40442LK H40442LM H40452LE H40452LG H40462LN H44901AE H45021RR H45021RT H45511EE H45511NT H45521CB H45521CK H45521DX H45521DY H45521JG H45521JH H45531HK H45531MZ H45531YM H45541MJ H45541MK H45541PX H45541RN H45541SD H45551MM H45551MN H45551MP H45551MR H45551MS H45551MT H45551NH H45551NK H45551NL H45551NM H45551ZD H45551ZE H45561AA H45561FC H45561FG H45561FJ H45561GG H45561GJ H45561GX H45561GY H45561MY H45561MZ H45561NA H45561NB H45561NC H45561ND H45561NE H45561RK H45561RT H45561RW H45561RX H45561RY H45561TA H45571FK H45571FS H45571FT H45571GG H45571GH H45571GJ H45571GK H45571GL H45571GZ H45571LS H45571PY H45571PZ H45571RA H45571RB H45571RD H45571RE H45571RJ H45571RK H45571RL H45581BJ H4830JE H4830JG H4906BK H4913BA