Holter ECG Machine
- Analysis ID
- 240001862/PCBB-HCM
- Submission ID
- 000.00.19.H29-240806-0008
- Product Type
- ER-2000SMART
- Manufacturer
- Ustation Inc.
- Product Owner
- Ustation Inc.
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN KOREA MEDICAL DEVICES ASSOCIATION (KMDA) TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- The device worn by the subject for a long time to record ECG and replay to interpret ECG
- Registration Date
- Aug 22, 2024
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Access comprehensive regulatory information for Holter ECG Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001862/PCBB-HCM and manufactured by Ustation Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN KOREA MEDICAL DEVICES ASSOCIATION (KMDA) TẠI THÀNH PHỐ HỒ CHÍ MINH.
This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including SVI Austria GmbH, Labtech Ltd., and 4 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.