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Singapore HSA registration DE0506815

GE Voluson P Series (P6, P8) BT22 Ultrasound Systems

Singapore flagSingapore·CLASS B·GE Ultrasound Korea, Ltd.·Registered April 22, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506815
Registration Date
April 22, 2022
Retention Due Date
April 21, 2026
Product description
This system is intended for ultrasound evaluation in the following clinical application: Image Acquisition for diagnostic purposes including measurements on acquired images. The device may be used by qualified physicians, sonographers, and healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Clinical applications include: Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Peripher vascular, Pediatrics, Cephalic, MSK, Breast and Small part.
Product Owner
Name
GE Ultrasound Korea, Ltd.
Short Name
GE Ultrasound Korea, Ltd.
Address
9, Sunhwan-ro, 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13204, KOREA, REPUBLIC OF
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)
3Sc-RS 4C-RS 12L-RS E8C-RS IC9B-RS Sterile Disposable Endocavity Needle Guide Kits Needle Guide Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit Needle Guide Biopsy Starter Kit RAB2-6-RS IC9-RS Needle Guide Needle Guide Needle Guide RIC5-9A-RS Voluson P6 Voluson P8
Model Identifier(s)
47237516 5125386 5141337 5318734 5835938 E8333JB E8385MJ E8385NA H40432LC H46222LC H48681GF H48681ML H48681WR H48691PJ H48691YW H48691YX H48691Z H48701EJ Voluson P6 BT22 Voluson P8 BT22
About this record

Access comprehensive regulatory information for GE Voluson P Series (P6, P8) BT22 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 DE0506815 and owned by GE Ultrasound Korea, Ltd.. The device was registered on April 22, 2022.

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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