Vietnam MOH registration 240001447/PCBB-HCM

Ultrasound Diagnostic Imaging System

VN: Hệ thống siêu âm chẩn đoán hình ảnh

Sonosite SII

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·FUJIFILM SonoSite, Inc.·Registered Jul 11, 2024

Registration details

Analysis ID: 240001447/PCBB-HCM
Submission ID: 000.00.19.H29-221219-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: FUJIFILM SonoSite, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: FUJIFILM SonoSite, Inc.
Authorized Representative: CÔNG TY TNHH FUJIFILM VIỆT NAM

Technical details

Intended Use: The Sonosite SII Ultrasound System is a diagnostic ultrasound system designed for use by physicians and healthcare professionals with the appropriate training to evaluate the body's anatomy by ultrasound imaging or to analyze the body's hemodynamics. Clinical applications include: Ophthalmology Obstetrics/Gynecology Abdomen Pediatrics Small organs (Breast, Thyroid, Testes, Prostate) Newborn head Adult head and neck Intestine Vagina Musculoskeletal Musculoskeletal Cardiology in adults Pediatric cardiology Peripheral vascular

Dates and status

Registration Date: Jul 11, 2024

About this record

Access comprehensive regulatory information for Ultrasound Diagnostic Imaging System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001447/PCBB-HCM and manufactured by FUJIFILM SonoSite, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH FUJIFILM VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. 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.