Vietnam MOH registration 2402039ĐKLH/BYT-HTTB

Oral Radiography System

VN: Hệ thống chụp X-quang nha khoa

Vietnam·Risk Class TTBYT Loại C·Owandy-RX DC·OWANDY RADIOLOGY·Registered Aug 27, 2024

Registration details

Analysis ID: 2402039ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230314-0028
Product Type: Owandy-RX DC

Company information

Manufacturer: OWANDY RADIOLOGY
Manufacturer Country: FRANCE
Authorized Representative: CÔNG TY TNHH VẠN NIÊN

Technical details

Intended Use: Owandy-RX DC is an X-ray machine designed for dental radiography, specifically, it is an external mouth X-ray source intended for creating diagnostic dental X-ray films to treat dental, jaw, and oral structure conditions. In clinical practice, Owandy-RX DC can be applied in routine dental radiography tests related to diagnosis, treatment, including surgery or intervention, and conditions of the dental, jaw, and oral structures. The intended medical applications of it are: • General Dentistry • Dental Implantology • Dental Surgery

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Oral Radiography System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402039ĐKLH/BYT-HTTB and manufactured by OWANDY RADIOLOGY. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

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