Vietnam MOH registration 2402310ĐKLH/BYT-HTTB

Panoramic Dental X-ray Machine

VN: Máy X-quang răng toàn cảnh
Vietnam flagVietnam·Risk Class TTBYT Loại C·I-MAX 3D·OWANDY RADIOLOGY SAS·Registered Aug 30, 2024
Registration details
Analysis ID
2402310ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230915-0008
Product Type
I-MAX 3D
Company information
Manufacturer Country
FRANCE
Product Owner
OWANDY RADIOLOGY SAS
Authorized Representative
CÔNG TY TNHH VẠN NIÊN
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.
Dates and status
Registration Date
Aug 30, 2024
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About this record

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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