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Siemens Acuson NX2 Diagnostic Ultrasound System - HSA Registration DE0018835

Access comprehensive regulatory information for Siemens Acuson NX2 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 DE0018835 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on December 28, 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
DE0018835
Siemens Acuson NX2 Diagnostic Ultrasound System
HSA Registration Number: DE0018835
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Product Description

The ACUSON NX2 ultrasound imaging system is intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal 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
DE0018835
Registration Date
December 28, 2016
Change Notification Approval Date
May 20, 2020
Retention Due Date
December 27, 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)
CIV- Flex Transducer Cover Biopsy Starter Kit Biopsy Starter Kit Transducer Cover Transducer Cover Needle Guide Needle Guide C8F3 Transducer CW2 CW5 EC9-4 Transducer P4-2 Transducer CH5-2ย Transducer VF10-5 Transducer ECG Cable and lead-wires ECG Cable and lead-wires Acuson NX2 Diagnostic Ultrasound System Acuson NX2 Elite Diagnostic Ultrasound System 10MC3 C5-2v Transducer L10-5v Transducer Biopsy Starter Kit Biopsy Starter Kit Needle Guide Needle Guide SW Install DVD NX2, NX2 Elite VA10C SW Install DVD NX2 VA11C SW Install DVD NX2 Elite/NX2 VA10D SW Install DVD NX2 Elite/NX2 VA11D SW Install DVD NX2 Elite/NX2 VA11E SW Install DVD NX2 Elite/NX2 VA11F ECG Electrode
Model Identifier(s)
04510947 04838749 07472314 08990418 08990426 10041822 10041823 10786652 10789380 10789381 10789383 10789385 10789386 10789387 11147443 11147444 11284381 11284500 11284842 11284925 11284926 11291775 11291776 11343996 11343997 11411351 11502812 11503671 11503672 11574523 11574769 1500-003