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Singapore HSA registration DE0507659

GE Versana Balance Ultrasound System

Singapore flagSingapore·CLASS B·GE Medical Systems (China) Co., Ltd.·Registered January 05, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0507659
Registration Date
January 05, 2023
Retention Due Date
January 04, 2026
Product description
The Versana Balance is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Balance clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).
Product Owner
Name
GE Medical Systems (China) Co., Ltd.
Short Name
GE Medical Systems (China) Co., Ltd.
Address
No. 19, Changjiang Road, WuXi National Hi-Tech Development, Zone Jiangsu, 214028, CHINA
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)
Needle Guide Biopsy Starter Kit 4C-RS E8C-RS 8C-RS 12L-RS Biopsy Starter Kit L8-18i-RS 12s-RS 6S-RS 3Sc-RS Biopsy Starter Kit L6-12-RS E8Cs-RS ECG ASSY W/ AHA CABLE ECG ASSY W/ IEC CABLE Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit RAB2-6-RS Versana Balance Versana Balance
Model Identifier(s)
E8385MJ E8385NA H4000SR H40402LN H40402LS H40402LY H40432LC H40462LF H44901AB H45021RP H45041DL H46222LC H48062AC H48062AF H48392BN H48392BP H48392LL H48392LT H48681ML H48681WR Versana Balance R2 VA Versana Balance R2 VS
About this record

Access comprehensive regulatory information for GE Versana Balance 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 DE0507659 and owned by GE Medical Systems (China) Co., Ltd.. The device was registered on January 05, 2023.

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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