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GE Logiq P5 Diagnostic Ultrasound System - HSA Registration DE0014814

Access comprehensive regulatory information for GE Logiq P5 Diagnostic 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 DE0014814 and owned by GE Ultrasound Korea, Ltd.. The device was registered on February 20, 2014.

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
DE0014814
GE Logiq P5 Diagnostic Ultrasound System
HSA Registration Number: DE0014814
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Product Description

Intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Fetal/ Obstetrics, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurological).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0014814
Registration Date
February 20, 2014
Change Notification Approval Date
September 05, 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
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
E8C/E8CS disposale E8C/E8CS disposale -guide and covers 3.5C/3.5CS Single Biopsy IC5-9-D Disposable Biopsy kit 12L single-angle 3S-02 multi-angle/5S-02 8L multi-angle 4C/5CS Multi-angle t739 multi-angle 10L multi-angle BE9C/BE9CS Disposal BE9C/BE9CS reusable 8L 5CS i12L ERB bridge (fixed) type biopsy guide i739 t739 ERB Stepper (grid) type biopsy guide E8C 10L 8C 3.5CS IC5-9-D Reusable Biopsy Kit 9L BE9C 11L 5S-02 7S-02 UG7C 11L multi-angle 3CRF 3CRF single-angle BE9CS ECG kit including AHA type ECG cable CW Doppler kit 3 probe Ports kit Probe cable hanger Additional Task lamp kit Endo probe holder BW Printer Fixture KBD BW Printer Fixture Middle Printer VCR DVD Fixture Top Color Printer Fixture Middle Rear Handle Swivel Lock Caster 4D UPGRADEKIT_PROBEHOLDER ECG Kit including IEC type ECG cable UPS Fixture brkt Kit LCD Flexible Arm kit 1 button Foot Switch 3 buttons Foot Switch ARC Switch Set BT09 Upkit BT09 Color UpKit for BT09 BW BT09 CPU Upkit for BT09 BW BT09 Color Upkit for BT06,BT08 BT09 CPU Upkit for BT06,BT08 P5BT09 Easy 3D(SW) Option P5BT09 Advanced 3D(SW) Option P5BT09 DICOM(SW) Option P5BT09 LOGIQ View Option P5BT09 Anatomical M Mode Option P5BT09 B-Flow option P5BT09 Report Designer P5BT09 CrossBeam Option P5BT09 CHA Option P5BT09 SRI HD Option Logiq P5 Logiq P5 Logiq P5 Logiq P5 Logiq P5 4D3C-L 4DE7C 4D8C E8CS ERB 3Sp Multi-angle biopsy 5Sp Multi-angle biopsy 3Sp 5Sp 4D3C-L, 4D5C-L single angle (Civco) 4D8C single angle (Civco) 4DE7C single-angle 3S-02 P2D P6D 4D3C-L, 4D5C-L single angle (Kretz) 4D8C single angle (Kretz) 3.5C 4C 9L multi-angle
Model Identifier(s)
E8333JA E8333JB E8385MG E8385MJ E8385MM E8385MZ E8385N E8385NA E8386RG E8386RJ E8387M E8387MA H4001DB H4001DC H4012L H40202E H40212LF H40212LM H40342LL H40412LE H40412LG H40412LJ H40412LK H40412LN H40412LT H40412LW H40412LY H40422LA H40422LB H40432LA H40432LC H40442LP H40442LR H40452LF H44402LN H44402LP H44402LS H44412LA H44412LD H44442LR H44442LT H44442LW H44442LY H44442LZ H44452LA H44472LY H44482LS H44482LW H44482LZ H44552LN H44552LR H44552LS H44592LA H44592LL H44592LM H44592LN H44592LP H44592LR H44602LA H44602LB H44602LC H44602LD H44602LE H44602LF H44602LG H44602LH H44602LJ H44602LK H44662LE H44662LY H44662LZ H44672LA H44672LB H44801G H44801GA H44801GZ H44801HR H45202ER H46222LC H46222LD H46222LE H46222LF H46701AE H46701AF H46721R H4701SZ H4830JE H4830JG H48621Y H48651DG H4901PE H4904PC H4906BK