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GE Voluson P6/Voluson P8 Ultrasound Systems - HSA Registration DE0501830

Access comprehensive regulatory information for GE Voluson P6/Voluson P8 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 DE0501830 and owned by GE Ultrasound Korea Ltd. The device was registered on July 02, 2018.

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
DE0501830
GE Voluson P6/Voluson P8 Ultrasound Systems
HSA Registration Number: DE0501830
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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 • Peripher V. • Pediatrics • Cephalic • MSK • Breast • Small Parts • Transvaginal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0501830
Registration Date
July 02, 2018
Retention Due Date
July 01, 2025
Product Owner
Short Name
Ge Ultrasound Korea Ltd
Address
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA, REPUBLIC OF
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)
Needle Guide (E8C-RS) Biopsy Starter Kit (4C-RS) 4C-RS E8C-RS 12L-RS Biopsy Starter Kit (12L-RS) Voluson P8 BT18 Voluson P8 BT18 - High Console Voluson P6 BT18 3Sc-RS Biopsy Starter Kit (3Sc-RS) Needle Guide (RIC5-9) Needle Guide (RIC5-9) Biopsy Starter Kit (RAB2-6-RS) RAB2-6-RS IC9-RS Needle Guide (IC9) Needle Guide (IC9) Needle Guide (RIC5-9) RIC5-9A-RS Needle Guide (IC9)
Model Identifier(s)
E8385MJ E8385NA H4000SR H40402LN H40402LY H40432LC H44952LB H44952LC H44952LD H45041DL H46222LC H46721R H48681GF H48681ML H48681WR H48691PJ H48691YW H48691YX H48691Z H48701EJ H48701MN