Automatic Cardiac Rhythm Disturbance Machine
- Analysis ID
- 2402084ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220420-0092
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Mediana Co., Ltd.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Mediana Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH IDS MEDICAL SYSTEMS VIỆT NAM
- 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.
- Registration Date
- Aug 27, 2024
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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.