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GE Voluson E10 Ultrasound System - HSA Registration DE0016786

Access comprehensive regulatory information for GE Voluson E10 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 DE0016786 and owned by GE Healthcare Austria GmbH & Co OG. The device was registered on February 02, 2015.

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
DE0016786
GE Voluson E10 Ultrasound System
HSA Registration Number: DE0016786
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Product Description

This system is intended for use by a qualified physician or sonographer for ultrasound evaluation in Image Acquisition for diagnostic purposes including measurements on acquired image. Clinical Applications: Abdomen, Obstetrics (incl. Fetal Cardio), Gynecology, Cardiology, Transrectal, Vascular, Cephalic, Small Parts (incl. Breast), Pediatrics, MSK.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0016786
Registration Date
February 02, 2015
Change Notification Approval Date
October 11, 2018
Retention Due Date
February 01, 2026
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)
IC5-9H E8C Needle Guide 4C Biopsy Starter Kit 4C-D E8C Reusable Guide Attachment 12L-RS Multi Starter Kit C1-5-D biospy starter kit ML6-15D Biopsy Starter Kit 11L-D IC5-9-D 9L-D C1-5-D ML6-15-D C2-9-D C1-6-D M5Sc-D L2-9-D S4-10-D Biopsy Starter Kit (M5Sc-D) 3Sp Biopsy Starter Kit RSP Biopsy Starter Kit RAB Biopsy Starter Kit PEC63 PEC75 P2D P6D PEC74 PEC76 RAB2-5-D RSP6-16-D RIC5-9-D RNA5-9-D RIC6-12-D PEC81 RM6C C4-8-D C4-8-D Biopsy Starter Kit 3Sp-D RAB6-D eM6C eM6C Biopsy Starter Kit RAB6 Biopsy Strarter Kit Voluson E10 BT17 Voluson E10 BT15 CW Voluson E10 BT15 IC9-D Needle Guide Needle Guide Upgr VE-series BT15 to BT16 Update new VE BT16 SW Voluson E10 BT16 CW – Doppler VE10 BT16 eM6CG2 Voluson E10 BT17 Upgrade VE-Series BT16 to BT17 Update new VE -Series BT17 Software eM6CG2 Biopsy starter kit Upgrade VE-Series BT15 to BT17 IC4-10-D Voluson E10 BT18 Voluson E10 BT18 OLED Monitor Upgrade VE-series BT17 to BT18 Update new VE -Series BT18 Software Voluson E10 BT19 Voluson E10 BT19 OLED Monitor Voluson E BT18 to BT19 UPG Voluson E BT19 new SW UPG Voluson E BT17 to BT19 UPG 9L Biopsy Starter Kit Biopsy Starter Kit (C2-9-D) Biopsy Starter Kit (C1-6-D)
Model Identifier(s)
E8385MJ E8385NA H4001BC H40412LN H40432LC H40432LE H40432LJ H40432LN H40442LK H40442LM H40452LE H40452LG H40462LN H40472LT H44901AE H44901AI H45302LA H45561FC H46222LC H46701AD H46701AE H46721R H46721W H4830JE H4830JG H48621Y H48651DG H48651MN H48651MR H48651MS H48651MY H48651NA H48651PN H48671ZG H48681AS H48681AT H48681AZ H48681MG H48681MJ H48681MK H48681ML H48691GU H48691RN H48691XK H48691XM H48691YW H48691YX H48691ZG H48691ZH H48701CJ H48701EF H48701ES H48701GT H48701GW H48701GX H48701MP H48701MS H48701NC H48701UY H48701UZ H48701WC H48701WD H48711DC H48711DD H48711DE H48711DF H48711DW H4906BK H4913BA H4913BB