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GE Voluson® P Series Ultrasound System - HSA Registration DE0012420

Access comprehensive regulatory information for GE Voluson® P Series 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 DE0012420 and owned by GE Ultrasound Korea, Ltd. The device was registered on February 20, 2013.

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
DE0012420
GE Voluson® P Series Ultrasound System
HSA Registration Number: DE0012420
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Product Description

This system is intended for use by a qualified physician for ultrasound evaluation in the following clinical applications: • Fetal/ Obstetrics • Abdominal/GYN (including infertility monitoring of follicle development), Pediatric • Small Organ (breast, testes, thyroid, etc.) • Cardiac (Adult and Fetal Cardiac) • Peripheral Vascular • Urology • Musculo-skeletal Conventional and Superficial • Transvaginal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0012420
Registration Date
February 20, 2013
Change Notification Approval Date
October 12, 2016
Retention Due Date
February 19, 2026
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
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
High Res. High Gloss Paper (UPP-100HG) BIOPSY FOR E8C, Disposable (20) ) BIOPSY FOR IC5-9H/E8C, DISPOSABLE (20) 4C BIOPSY STARTER KIT 4C-RS E8C-RS 12L-RS BIOPSY FOR IC5-9H/E8C, REUSABLE 12L Biopsy Kit B&W Printer Digital (SONY, UP-D897) Color Printer Digital (SONY, UP-D25MD) BT15 Voluson P8 Console BT15 Voluson P8 Console High BT15 Voluson P8 Console for HDlive BT14 to BT15 SW UPKIT for VP8 17 inch LCD Monitor UPKIT for VP8 Voluson P8 BT16 Console Voluson P8 BT16 Console High Voluson P6 BT16 Console 3Sc-RS ECG Cable - AHA ECG cable - IEC DVD+RW Disc blank 3Sc biospy kit (multi-angle) Connection Module Report Data CWD Upgrade kit for VP8 PEC78; Biopsy for RAB RAB2-5-RS Extender Kit Printer Filler Cover Printer installation kit (BW and Color) PEC63; Biopsy for RIC5-9 (<1.6 mm) USB FootSwitch - 3 Buttons Horizontal TV Holder Vertical TV Holder DVR Module CWD Upgrade kit for VP8 ECG Option Kit PAPER LARGE FOR SONY UP21/23 PAPER SMALL FOR SONY UP21/23 Base console for VP6 Base console for VP8 Voluson P6 - High Console Voluson P8 - High Console BT14 Voluson P8 Console BT14 Voluson P8 Console High BT14 Voluson P6 Console BT14 Voluson P6 Console High BT14 SW UPKIT for VP8 BT14 SW UPKIT for VP6 HDlive Full Set (for IB) HDlive Full Set (for MC) UVC full set for Voluson P6_P8 CPS with Battery Pack CPS with Battery Pack (MC only) HDlive Hdlive for MC only UVC INSTALLATION KIT VOLUSON P6_P8 BT14 Voluson P8 Console for HDLive PEC74; Biopsy for RAB DVD+RW Disc blank RIC5-9W RS Bluetooth Line Printer EU+USA Line Printer Dest Set ROW WLAN Stick RIC Biopsy Starter Kit RAB 2-6 multiangle – disposable - biopsy guide 32" Secondary Monitor US 32 inch Monitor RAB2-6-RS 4DView PC Software IC9-RS RIC Biopsy Starter Kit With Latex Cover RIC5-9A-RS
Model Identifier(s)
E8310KD E8333JB E8385MJ E8385NA H4000SR H40402LN H40402LY H40412LN H40432LC H44492LB H44642LW H44762LK H44762LL H44762LM H44762LY H44772LB H44802LC H44802LD H44802LE H45041DL H45302LY H45302LZ H46102LT H46222LC H46681S H46692LY H46701AE H46701NA H46712CE H46712CF H46712CG H46721R H46732LF H46732LJ H46732LK H46772LJ H46802LA H46802LC H46851B H46861B H46872LT H46872LY H46872MA H46872MB H46902LJ H46902LK H46902LL H46902LM H46912LT H46912LW H46922LJ H46922LK H46952LB H46972LM H46972LN H46982LT H46982LW H46992LB H46992LC H48621Y H48641D H48661EF H48661MT H48661MW H48671DT H48681GF H48681ML H48681TL H48681TP H48681WR H48691KL H48691PJ H48691Z H48701EJ