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GE LOGIQ Book XP Series Ultrasound system - HSA Registration DE0009512

Access comprehensive regulatory information for GE LOGIQ Book XP 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 DE0009512 and owned by GE Medical Systems (China) Co., Ltd.. The device was registered on August 15, 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
DE0009512
GE LOGIQ Book XP Series Ultrasound system
HSA Registration Number: DE0009512
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Product Description

The LOGIQ Book XP Series 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 Parts (breast, neck, thyroid, prostate, limbs and extremities) • Obstetric • Gynecology • Cardiac (adult and pediatric) • Vascular • Urology (including prostate) • Transrectal • Transvaginal • Intraoperative

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0009512
Registration Date
August 15, 2012
Retention Due Date
August 14, 2025
Product Owner
Short Name
GE Medical Systems
Address
No. 19, Changjiang Road, Wuxi, Jiangsu, 214028, CHINA
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)
Biopsy kit for E8C-RS transducer Biopsy kit 3S-RS transducer Biopsy kit for 8L-RS transducer Biopsy kit for 3C-RS transducer PAP.B&W Sony UP-110HG/5 3S-RS Phased array transducer i739-RS Linear array surgical transducer 3C-RS Convex array transducer E8C-RS Intracavitary microconvex array transducer 8C-RS Microconvex array transducer 8L-RS Linear array transducer i12L-RS Linear ‘hockey stick’ array transducer E8C-RS Re-Usable Biopsy Manuals English Biopsy kit for E8C-RS transducer re-usable T739-RS Linear array surgical transducer T739-RS OP Manuals English i739-RS OP Manuals English DVD R/W Europe LOGIQ Book XP Compact digital Ultrasound console Continental Europe LB XP PRO Compact digital Ultrasound console w/ color, doppler Continental Europe LBXP Enhanced upgrade LBXP PRO Enhanced upgrade Sony UPP-110HG B/W Printer Paper 1 roll LOGIQ Book footswitch Battery pack Measure transfer connection kit DICOM w/2 net card option Easy3D option USB hub assembly Wireless LAN card - Cisco Network Card FA511 AC/DC power cable UK/Ireland AC/DC power cable India/South Africa AC/DC adapter Sony UP-D23MD Color paper printer EU Kit carrying case (hard cover) 3 meter USB cable DICOM option Easy3D option HP460 Printer EU Kits (HP460+PIT) PC Printer EU (HP Pro K550) Isolation Cart EU Isolation Cart India Color option Doppler option ECG module (AHA) ECG module (IEC) PWD upgrade CFM upgrade CFM/PW upgrade Sony UP-D897 black & white paper printer EU kit carrying case Transducer Manual E8C-RS OP English USB Memory Stick (SanDisk USB Stick 1G)
Model Identifier(s)
E8385MJ E8385MZ E8385N E8386RK EN0473 H4000PD H40402LJ H40402LL H40402LN H40402LS H40402LT H40402LW H40411L H40412LN H40412LP H40492LC H40492LL H40812LD H40952LH H40952LL H40972LA H40972LC H41402LS H41412LH H41422LF H41422LM H41442LK H41442LM H41452LE H41472LE H41472LG H41472LN H41472LR H41472LY H41482LG H41482LL H41482LM H41552LA H41552LB H41552LE H41552LH H41552LR H41552LY H41562LS H41562LT H41572LZ H41592LR H41622LM H41622LN H41622LP H41642LZ H41652LC H44801GK H48092LT