Vietnam MOH registration 2403044ĐKLH/BYT-HTTB

Hematologic Treatment System Using Ultrasound

VN: Hệ thống điều trị huyết khối bằng sóng siêu âm

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Boston Scientific·Registered Nov 02, 2024

Registration details

Analysis ID: 2403044ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231014-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Boston Scientific
Manufacturer Country: Theo theo phụ lục
Product Owner: Boston Scientific
Authorized Representative: CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM

Technical details

Intended Use: The EKOS 4.0 ultrasound generator is designed to be used with the EKOS thrombolytic treatment kit, which uses high-frequency ultrasound (2 MHz - 3 MHz) at low power to facilitate the delivery of the physician-prescribed liquid, including the liquid used in the procedure and the thrombolytic agent, into the lungs and/or peripheral blood vessels of adults. The EKOS thrombolytic treatment kit is designed to be used with the EKOS control system to use high-frequency ultrasound (2 MHz -3 MHz) at low power to facilitate the delivery of the physician-prescribed liquid, including the surgical liquid and the thrombolytic agent, into the pulmonary arteries and/or peripheral blood vessels of adults. It is intended for use by physicians who are knowledgeable about the percutaneous transluminal angioplasty procedure. The EKOS thrombolytic treatment kit is not designed for use in the central nervous system arteries. The target patient population is adults with symptomatic pulmonary thrombosis and/or peripheral vascular thrombosis, such as the iliac and femoral arteries. Refer to the product information leaflet provided with the physician-prescribed liquid for information on the preparation of the specific liquid, contraindications, side effects, warnings, and precautions. The EKOS thrombolytic treatment kit is indicated for: •the treatment of patients with pulmonary thrombosis with ≥ 50% occlusion of one or both main pulmonary arteries or a lobar artery, and who have evidence of right heart dysfunction based on right heart pressure (pulmonary artery mean pressure ≥ 25 mmHg) or echocardiography. •the delivery of the physician-prescribed liquid, including the thrombolytic agent, into the peripheral arteries and the pulmonary arteries.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for Hematologic Treatment System Using Ultrasound in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403044ĐKLH/BYT-HTTB and manufactured by Boston Scientific. The authorized representative in Vietnam is CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. 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.