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Siemens Acuson NX3 Elite Ultrasound System - HSA Registration DE0018244

Access comprehensive regulatory information for Siemens Acuson NX3 Elite 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 DE0018244 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on June 14, 2016.

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
DE0018244
Siemens Acuson NX3 Elite Ultrasound System
HSA Registration Number: DE0018244
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Product Description

The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018244
Registration Date
June 14, 2016
Change Notification Approval Date
June 23, 2023
Retention Due Date
June 13, 2025
Product Owner
Short Name
Siemens Medical Solutions USA, Inc.
Address
22010 S.E. 51st Street, Issaquah, WA 98029, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Needle Guide Needle Guide VF12-4 C8-5 Biopsy Starter Kit Biopsy Bracket VF16-5 C8F3 Biopsy Starter Kit EC10-5w Needle Guide Needle Guide Biopsy Bracket CW2 CW5 EC9-4 P4-2 CH5-2ย  VF10-5 P8-4 Needle Guide ECG Cable and lead-wires ECG Cable and lead-wires Acuson NX3 Elite Ultrasound System 10MC3 BP10-3 Needle Guide Needle Guide Needle Guide Needle Guide V5Ms 11L4 SW Install DVD, NX3 Elite/ NX3 VA10G SW Install DVD, NX3 Elite/ NX3 VB20C SW Install DVD NX3 Elite/NX3 VA10H SW Install DVD NX3 Elite/NX3 VB20D SW Install DVD NX3 Elite/NX3 VB20E SW Install DVD NX3 Elite/NX3 VB20F Adult ECG Electrode CIV- Flex Transducer Cover Biopsy Starter Kit VF13-5 SP Biopsy Starter Kit Transducer Cover Transducer Cover
Model Identifier(s)
10041822 10041823 10136922 10348181 10658470 10658471 10785041 10786652 10787043 10787072 10787095 10787096 10787350 10789380 10789381 10789383 10789385 10789386 10789387 10789389 11014271 11147443 11147444 11235411 11284842 11336164 11336182 11336183 11343996 11343997 11361462 11361584 11411391 11503108 11503673 11503674 11574496 11574770 1500-003 4510947 4838749 7471506 7472314 8990418 8990426