Panoramic Dental X-ray Machine - Vietnam Registration 2402310ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Panoramic Dental X-ray Machine 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 2402310ĐKLH/BYT-HTTB and manufactured by OWANDY RADIOLOGY SAS. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including De Gotzen S.r.l, De Gotzen S.r.l thuộc Acteon Group, and 5 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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2402310ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2402310ĐKLH/BYT-HTTB

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Device Details

Panoramic Dental X-ray Machine

VN: Máy X-quang răng toàn cảnh

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2402310ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-230915-0008

Product Type

I-MAX 3D

Technical Details

Intended Use

I-MAX 3D is a dental panoramic outside mouth and CBCT (also called CBVT) X-ray device for two-dimensional (panoramic, TMJ and sinus examination) or three-dimensional X-ray of teeth, jaws and mouth structure. Two-dimensional images are captured using the narrow-beam X-ray technique. The three-dimensional tests are performed using the cone-beam X-ray technique; both are well-known techniques. This device is operated and used by dentists, radiologists, and other qualified healthcare professionals. It can be used for both children and adults.