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GE Logiq P6 Diagnostic Ultrasound System - HSA Registration DE0014464

Access comprehensive regulatory information for GE Logiq P6 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 DE0014464 and owned by GE Ultrasound Korea, Ltd. The device was registered on December 17, 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
DE0014464
GE Logiq P6 Diagnostic Ultrasound System
HSA Registration Number: DE0014464
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Product Description

The LOGIQ P6/P6 Pro is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including 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
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0014464
Registration Date
December 17, 2013
Change Notification Approval Date
March 31, 2014
Retention Due Date
December 16, 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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
DB VIEWER Elastography on ML6-15/11L P6 BT11 Auto IMT Biopsy Kit E8C, E8CS Biopsy Kit E8C, E8CS E8C/E8CS Needle Guide Biopsy Kit 3S-02 Biopsy Kit 8L Biopsy Kit 4C, 5CS Biopsy Kit t739 Biopsy Kit BE9C, BE9CS Biopsy Kit BE9C, BE9CS 8L 5CS i12L Biopsy Kit ERB i739 t739 Biopsy Kit ERB E8C 8C Biopsy Kit E8C, E8CS 9L BE9C 11L 5S-02 7S-02 UG7C Biopsy Kit 11L Biopsy Kit ML6-15 3CRF Biopsy Kit 3CRF BE9CS Biopsy Kit 3CRF multi-angle ML6-15L 4D3C-L 4DE7C 4D8C E8CS 4D5C ERB 6TC LogipP6 BT11 VET P6 BT09 Easy 3D P6 BT09 Advanced 3D P6 BT09 DICOM 3.0 connectivity P6 BT09 LOGIQ View P6 BT09 B-Flow P6 BT09 Anatomical M Mode P6 BT09 Report Designer P6 BT09 CrossBeam P6 BT09 CodedContrast P6 BT09 SRI HD P6 BT09 StressEcho P6 BT09 PFD P6 BT09 TVI / Qanaysis P6 BT09 PDF Writer ECG Lead wire ECG Lead wire Logiq P6 BT09 for Asia Logiq P6 Pro Pro BT09 for Asia 3Sp 5Sp Biopsy Kit 3Sp Multi-angle biopsy Biopsy Kit 5Sp Multi-angle biopsy 3SP 5SP Logiq P6 BT11 FOR ASEAN Biopsy Kit 4D3C-L Biopsy Kit 4D8C Biopsy Kit 4DE7C 3S-02 P2D P6D Biopsy Kit 4D3C-L Biopsy Kit 4D8C 4C Biopsy Kit 9L 6Tc
Model Identifier(s)
5341806 5394960 5394961 E8333JA E8333JB E8385MJ E8385MZ E8385N E8385NA E8386RG E8387M E8387MA H4001DB H4001DC H4012L H40202E H40212LF H40212LM H40342LL H40412LE H40412LJ H40412LN H40412LT H40412LW H40412LY H40422LA H40422LB H40432LA H40432LC H40432LJ H40442LP H40442LR H40452LF H40452LP H40452LY H44801G H44801GA H44801GZ H44801HR H44801HT H45202ER H45551ZD H46012LA H46092LL H46092LM H46092LN H46092LP H46092LR H46092LS H46092LT H46092LW H46092LY H46092LZ H46102LA H46102LB H46102LC H46102LD H46102LH H46102LJ H46172LF H46172LS H46222LA H46222LB H46222LC H46222LD H46222LE H46222LF H46242LC H46701AE H46701AF H46721R H4701SZ H4830JE H4830JG H48621Y H48651DG H4904PC H4906BK KN100105