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Singapore HSA registration DE0504986

GE Voluson E Series Ultrasound Systems

Singapore flagSingapore·CLASS B·GE Healthcare Austria GmbH & Co OG·Registered September 28, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0504986
Registration Date
September 28, 2020
Retention Due Date
September 27, 2026
Product description
This system is intended for use by a qualified physician or sonographer for ultrasound evaluation in the following clinical application: Image acquisition for diagnostic purposes including measurements on acquired image. Clinical applications: Abdomen, Obstetrics (incl. Fetal Cardio), Gynecology, Cardiology, Transrectal, Vascular, Cephalic, Pediatrics, MSK, Small Parts (incl. Breast)
Product Owner
Name
GE Healthcare Austria GmbH & Co OG
Short Name
GE Healthcare Austria
Address
Tiefenbach 15, 4871 Zipf, AUSTRIA
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
RM7C eM6C G3 Needle Guide Biopsy Starter Kit 4C-D Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit 11L-D IC5-9-D 9L-D C1-5-D ML6-15-D L8-18i-D C2-9-D C1-6-D M5Sc-D S4-10-D Biopsy Starter kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit RAB2-5-D RSP6-16-D RIC5-9-D RIC6-12-D RM6C C4-8-D Biopsy Starter Kit 3Sp-D Needle Guide RAB6-D eM6C Biopsy Starter Kit Biopsy Starter Kit eM6C G2 Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Voluson E10 Voluson E6 Voluson E8
Model Identifier(s)
5790293 5835134 E8385MJ E8385NA H4001BC H40432LC H40432LE H40432LJ H40432LN H40442LK H40442LM H40452LE H40452LG H40452LL H40462LN H40472LT H44901AE H45302LA H45561FC H46222LC H46701AD H46701AE H48651MN H48651MR H48651MS H48651NA H48671ZG H48681AS H48681AT H48681AZ H48681GF H48681MG H48681MJ H48681MK H48681ML H48701ES H48701MP H4906BK H4913BA H4913BB Voluson E10 BT21 Voluson E6 BT21 Voluson E8 BT21
About this record

Access comprehensive regulatory information for GE Voluson E Series Ultrasound Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504986 and owned by GE Healthcare Austria GmbH & Co OG. The device was registered on September 28, 2020.

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 DatabasePowered by Pure Global AIHSA Official DataCLASS B