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GE Venue 40 Compact ultrasound system - HSA Registration DE0009511

Access comprehensive regulatory information for GE Venue 40 Compact 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 DE0009511 and owned by GE Medical Systems (China) Co., Ltd.. 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
DE0009511
GE Venue 40 Compact ultrasound system
HSA Registration Number: DE0009511
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Product Description

The Venue 40 is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: • Fetal/OB • Abdominal (including GYN and Urological) • Pediatric • Small Organ (including breast, testes and thyroid) • Neonatal Cephalic • Adult Cephalic (Transcranial) • Cardiac (including Adult and Pediatric) • Peripheral Vascular • Musculoskeletal Conventional • Musculoskeletal Superficial • Thoracic/Pleural • Interventional guidance (Tissue Biopsy/Fluid Drainage, Vascular Access) • Intraoperative (including abdominal, thoracic and peripheral) • Nonvascular (including Nerve Block)

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0009511
Registration Date
August 15, 2012
Retention Due Date
August 14, 2025
Product Owner
Short Name
GE Medical Systems
Address
No. 19, Changjiang Road, Wuxi, Jiangsu, 214028, CHINA
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)
3S biopsy kit 4C biopsy kit 12L-RS Multi Angle Biopsy Starter Kit 12L-SC probe 3S-SC probe 4C-SC probe UPP-110HG BW Paper 1 roll AC Adapter Cord UK AC Adapter Cord India B/W Printer (UP-D897) EU Kit Power cable India Power cable UK/Ireland Venue 40 VASCULAR ACCESS SW Venue 40 Regional Anesthesia SW Venue 40 MSK SW Venue 40 Point of Care SW Color & PDI option License SL for Vascular Access SL for Regional Anesthesia Vasc. Acc. Preset option kit  Reg. Anesth. preset option kit  3S General Imaging Preset Venue 40 Docking Station Venue Docking Cart Printer Installation Kit Basket Option for Cart Venue 40 Interventional SW Interventional Preset option kit  Musculoskeletal Preset option kit  SL for Point of Care Venue 40 CONSOLE ENG KIT SL for Musculoskeletal SL for Interventional Venue Docking Station UK Venue Docking Station India Venue Docking Cart UK Venue Docking Cart India Venue 40 CONSOLE ENG - light Venue 40 Console ENG – light Film Venue 40 VASCULAR ACCESS Venue 40 Regional Anesthesia Venue 40 MSK Venue 40 Point of Care Venue 40 Interventional Venue 40 Pleural Preset Option Venue 40 4C-General Option kit Venue 40 4C-Advanced Option kit Light Version Upg. Kit
Model Identifier(s)
E8385MZ E8385NA H40432LC H40452LB H40452LD H40452LM H41402LS H41472LN H41472LR H41642LZ H48062LK H48092LM H48302LY H48302LZ H48312LA H48312LB H48312LC H48312LD H48312LE H48312LF H48312LG H48312LH H48312LJ H48312LK H48312LL H48312LM H48332LJ H48332LK H48332LL H48332LM H48332LP H48332LR H48332LS H48342LK H48342LM H48342LY H48392LC H48392LG H48392LJ H48392LM H48392LN H48392LP H48392LR H48392LS H48392LW H48392LY H48392LZ H48402LA