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GE Logiq S7 Expert & Logiq S7 Pro - HSA Registration DE0011641

Access comprehensive regulatory information for GE Logiq S7 Expert & Logiq S7 Pro in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011641 and owned by GE Ultrasound Korea, Ltd. The device was registered on November 21, 2012.

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
DE0011641
GE Logiq S7 Expert & Logiq S7 Pro
HSA Registration Number: DE0011641
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Product Description

The LOGIQ S7 Expert/Pro is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Fetal/Obstetrics, Abdominal (includes renal, GYN/Pelvic), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Urology (including prostate), Transrectal, Transvaginal, Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0011641
Registration Date
November 21, 2012
Change Notification Approval Date
March 31, 2014
Retention Due Date
November 20, 2025
Product Owner
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)
Disposable Endocavity Needle GuideFor use with GE Healthcare’s E72, E721, E8C, E8C-RS, E8CS, IC5-9-D, IC5-9H, MTZ and MZ transducers 8C REUSABLE IC5-9-D Reusable Biopsy Kit Ultra-Pro II™ Needle Guidance System for use with GE Healthcare 11L, 11L-D, 12L-RS and 12L-SC transducers Ultra-Pro II needle guide for use with GE Healthcare C1-5-D transducer Ultra-Pro II™ Needle Guidance System for use with GE Healthcare ML6-15-D transducer 11L-D IC5-9-D 9L-D Ultra-Pro II needle guide for use with GE Healthcare for use with GE Healthcare 3CRF transducer C1-5-D L8-18i-D 3CRF BIOPSY ATTACHMENT(Multi) ML6-15 3CRF-D Probe Cable Hanger B&W Printer Digital (SONY, UP-D897) Color Printer Digital (SONY, UP-D25MD) S4-10-D Vert Endo Prb Holder LS7 Side Probe Holder DVR Module Ultra-Pro II™ Needle Guidance System for use with GE Healthcare 3Sp and 3Sc-RS ultrasound transducers Ultra-Pro II™ Needle Guidance SystemFor use with GE Healthcare RAB4-8L, RAB2-5-D, RAB2-5-RS, RAB4-8-D, RAB4-8-RS and 4D3CL transducers USB FootSwitch - 3 Buttons Printer installation kit (BW and Color) HDMI to VGA Video Converter Kit LOGIQ S7 Expert LOGIQ S7 Pro Advanced 3D Auto IMT B-Flow Coded Contrast Img CW Doppler DICOM Elastography Elasto QA Flow QA LOGIQView Report Writer Scan Assistant Stress Echo TVI B Steer+ Real Time 4D 4D TUI SW 3D Static Color Volume Review Vocal VCI Static LS7 Exp/Pro ECG Module ECG Cable - AHA ECG Cable - IEC CR Mounting Kit Articulating Monitor Arm LS7 Exp/Pro Pencil CW Kit 4D kit LOGIQ Gel Warmer P2D P6D PEC74; Biopsy for RAB RAB4-8-D 3Sp-D Sony UP-D55 Color A5 Ultra-Pro II™ Needle Guidance System for use with GE Healthcare 9L, 9L-D and 9L-RS transducers
Model Identifier(s)
E8385MJ H40412LJ H40412LN H40432LC H40432LE H40432LJ H40432LN H40442LK H40442LM H40442LR H40452LE H40452LL H40452LP H40452LY H40462LK H44412LA H44492LB H44642LW H45302LA H45302LK H45302LL H45302LT H46222LC H46701AE H46732LF H46762LS H46772LE H46832LK H46832LT H46862LE H46862LF H46862LG H46862LH H46862LJ H46862LK H46862LL H46862LM H46862LN H46862LP H46862LR H46862LS H46862LT H46862LW H46862LY H46862LZ H46872LA H46872LB H46872LC H46872LD H46872LE H46872LF H46872LG H46872LH H46872LN H46872LP H46882LA H46882LD H46882LG H4830JE H4830JG H48621Y H48651MP H48681AZ H4904PA H4906BK