Singapore HSA registration DE0506310
Alpinion X-Cube 90 Diagnostic Ultrasound System
Singapore·CLASS B·ALPINION MEDICAL SYSTEMS Co., LTD.·Registered October 21, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0506310
- Registration Date
- October 21, 2021
- Retention Due Date
- October 20, 2025
Product description
The intended use of the product is to collect ultrasound image data that may be used by clinicians for diagnostic and procedural purposes. The X-CUBE 90 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in 2D, 3D/4D, M (including anatomical M mode), pulsed wave Doppler, countinuous wave Doppler, color Doppler, tissue Doppler imaging modes. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal, Trans- vaginal, Musculo-skeletal (Conventional); Musculo- skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vessel (PV); and Urology (including prostate)
Product Owner
- Short Name
- ALPINION MEDICAL SYSTEMS Co., LTD.
- Address
- 5FL, I Dong, 77, Heungan-daero, 81beon-gil, Dongan-gu,, Anyang-si, Gyeonggi-do,, KOREA, REPUBLIC OF
Registrant
- Address
- 38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Importer
- Address
- 38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Model information
- Model Name(s)
- 2M Pencil Probe Endocavity Transducer Endocavity Transducer Linear Array Transducer Linear Array Transducer Phased Array Transducer Convex Array Transducer Linear Array Transducer Volume Convex Transducer Volume Endocavity Transducer Alpinion X-Cube 90
- Model Identifier(s)
- CW 2.0 EC2-11H EV2-11H L10-25H L3-12X MP1-5X SC1-7H SL3-19H SVC1-8H VE3-10H X-Cube 90
About this record
Access comprehensive regulatory information for Alpinion X-Cube 90 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 DE0506310 and owned by ALPINION MEDICAL SYSTEMS Co., LTD.. The device was registered on October 21, 2021.
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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