Vietnam MOH registration 2402084ĐKLH/BYT-HTTB

Automatic Cardiac Rhythm Disturbance Machine

VN: Máy phá rung tim tự động
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Mediana Co., Ltd.·Registered Aug 27, 2024
Registration details
Analysis ID
2402084ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-220420-0092
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer
Mediana Co., Ltd.
Manufacturer Country
Theo theo phụ lục
Product Owner
Mediana Co., Ltd.
Technical details
Intended Use
HeartOn A15-G4: Automatically defibrillating device that provides rapid defibrillation therapy and can operate on battery power. Intended for hospital use; emergency care in public; home health care. HeartOn A16-DS / HeartOn A16-DF: AED intended for use in treating non-responsive, non-breathing, and pulseless individuals, including adults and children (infants and toddlers) in all areas such as hospitals, pre-hospital, public access, alternative care and home health care settings. The AED is designed to be user-friendly. Note: The intended patient population is adults and children (infants and toddlers) (ages 1 to 8 or weighing less than 25 kg (55 lb)) who may be treated with an appropriate pad.
Dates and status
Registration Date
Aug 27, 2024
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About this record

Access comprehensive regulatory information for Automatic Cardiac Rhythm Disturbance 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 2402084ĐKLH/BYT-HTTB and manufactured by Mediana Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH IDS MEDICAL SYSTEMS VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Nihon Kohden, and 2 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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