Vietnam MOH registration 2403499ĐKLH/BYT-HTTB

Portable X-ray Machine

VN: Máy chụp X-quang xách tay
Vietnam flagVietnam·Risk Class TTBYT Loại C·Elpo-32·DK Medical Systems Co., Ltd.·Registered Nov 14, 2024
Registration details
Analysis ID
2403499ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-231219-0008
Product Type
Elpo-32
Company information
Manufacturer Country
REPUBLIC OF
Product Owner
DK Medical Systems Co., Ltd.
Authorized Representative
CÔNG TY CỔ PHẦN MEDITRONIC
Technical details
Intended Use
Elpo-32 is used in medical imaging, supporting the diagnosis of bone fractures, joint dislocation, and is a surgical tool – helping the surgeon perform the operation accurately. It is used to diagnose bone and joint conditions such as certain types of cancer, arthritis, or osteoporosis, and to diagnose conditions in the chest such as pneumonia, lung cancer, heart failure, etc., it can detect foreign objects such as metal fragments or coins swallowed by the patient. Elpo-32 can be used in any position on the patient, regardless of gender and age, including children. Indications for use: Women who are pregnant or who may become pregnant should use it only as directed by a doctor.
Dates and status
Registration Date
Nov 14, 2024
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About this record

Access comprehensive regulatory information for Portable 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 2403499ĐKLH/BYT-HTTB and manufactured by DK Medical Systems Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN MEDITRONIC.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including PROTEC GmbH & Co. KG, OR Technology (Oehm und Rehbein GmbH) , 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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