Vietnam MOH registration 240002041/PCBB-HCM

Ultrasound Diagnosis System

VN: Hệ thống siêu âm chẩn đoán
Vietnam flagVietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Edan Instruments, Inc.·Registered Sep 11, 2024
Registration details
Analysis ID
240002041/PCBB-HCM
Submission ID
000.00.19.H29-240905-0004
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
Edan Instruments, Inc.
Technical details
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.
Dates and status
Registration Date
Sep 11, 2024
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About this record

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.

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