Singapore HSA registration DE0503715
Siemens ACUSON Redwood Diagnostic Ultrasound System
Singapore·CLASS B·Siemens Medical Solutions USA, Inc.·Registered October 08, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0503715
- Registration Date
- October 08, 2019
- Change Notification Approval Date
- January 22, 2025
- Retention Due Date
- October 07, 2025
Product description
The ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures: fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
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 Transducer cover Biopsy Starter Kit Biopsy Starter Kit Tracking Bracket Starter Kit Needle Guide Needle Guide 10L4 9EC4 CW2 CW5 V5Ms 4V1 8V3 10V4 ECG Lead, USA Type(AHA) ECG Lead, Euro Type(IEC) 14L5 Siemens 10L4 Siemens 14L5 Siemens 5C1 9VE4 7VC2 18H6 5C1 5V1 Acuson Redwood 9C3 18L6 Adult ECG Electrode
- Model Identifier(s)
- 04510947 08990426 10044200 10136145 10441187 10659481 10659482 10787114 10787117 10789380 10789381 11013704 11014576 11014578 11014579 11147098 11148104 11254090 11287649 11287650 11287651 11289564 11289565 11289567 11291794 11291796 11503314 11575182 11575184 1500-003
About this record
Access comprehensive regulatory information for Siemens ACUSON Redwood 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 DE0503715 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on October 08, 2019.
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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