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Singapore HSA registration DE0510399

GE Voluson Expert (18, 20, 22) Series Ultrasound Systems

Singapore flagSingapore·CLASS B·GE Healthcare Austria GmbH & Co OG·Registered February 27, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0510399
Registration Date
February 27, 2025
Retention Due Date
February 26, 2026
Product description
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
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)
6S-D 11L-D 9L-D IC5-9-D ML6-15-D L8-18i-D C2-9-D C1-6-D M5Sc-D RM7C eM6C G3 RIC10-D RAB7-D Needle Guide Biopsy Starter Kit Biopsy Starter Kit Needle Guide Needle Guide Needle Guide Biopsy Starter kit Biopsy Starter Kit RSP6-16-D RIC5-9-D RIC6-12-D Needle Guide RAB6-D Biopsy Starter Kit ECG ASSY W/ IEC CABLE Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Voluson Expert 18 Voluson Expert 20 Voluson Expert 22
Model Identifier(s)
47236955 5176269 5194432 5194434 5199103 5336965 5405253 5418916 5446812 5790293 5835134 5845346 5929364 E8385MJ H40432LC H40432LJ H44901AW H44901AX H44901AY H45561FC H46701AD H48651MR H48651MS H48651NA H48681GF H48681MG H48681ML H48711KX H4906BK H4913BA H4913BB Voluson Expert 18 BT25 Voluson Expert 20 BT25 Voluson Expert 22 BT25
About this record

Access comprehensive regulatory information for GE Voluson Expert (18, 20, 22) 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 DE0510399 and owned by GE Healthcare Austria GmbH & Co OG. The device was registered on February 27, 2025.

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