Ultrasound Diagnosis System
- Analysis ID
- 240002041/PCBB-HCM
- Submission ID
- 000.00.19.H29-240905-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Edan Instruments, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Edan Instruments, Inc.
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ Y TẾ THIÊN NAM
- Intended Use
- Acclarix, a Doppler ultrasound diagnostic system, is designed for use by qualified physicians or related medical specialists to evaluate ultrasound at hospitals and clinics. Clinical applications include the abdomen, gynecology, obstetrics, heart, small parts, urology, musculoskeletal, peripheral blood vessels, intraoperative, pediatrics, neonatology, and adults. The operating modes of the Acclarix Doppler ultrasound diagnostic system include the B mode, M mode, Doppler mode, Harmonic imaging, Tissue Doppler, Contrast imaging, and combinations of these.
- Registration Date
- Sep 11, 2024
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Access comprehensive regulatory information for Ultrasound Diagnosis System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002041/PCBB-HCM and manufactured by Edan Instruments, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ THIÊN NAM.
This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Theo theo phụ lục, Sonoscape Medical Corp., and 3 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.