Vietnam MOH registration 2400455ĐKLH/BYT-HTTB

Myocardial Infusion Device Pump

VN: Máy bơm dung dịch khi đốt cơ tim

Vietnam·Risk Class TTBYT Loại C·Qiona Pump·Möller Medical GmbH·Registered Apr 10, 2024

Registration details

Analysis ID: 2400455ĐKLH/BYT-HTTB
Submission ID: 17002739/ĐKLH-BYT-TB-CT
Product Type: Qiona Pump
Product Code: 406935

Company information

Manufacturer: Möller Medical GmbH
Manufacturer Country: GERMANY
Product Owner: Möller Medical GmbH
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: The Qiona® cardiac tissue ablation solution pump is used in conjunction with the catheter and sterile container containing the normal saline solution, with the aim of cooling the catheter tip during the ablation process. The combined ablation and cooling technique is a special interventional approach applied to particularly sensitive areas. During the ablation treatment, a malfunctioning cardiac conduction system in the ventricular wall can be destroyed by heating the tissue with high-frequency current. The Qiona® cardiac tissue ablation solution pump is used in the catheterization laboratories under clinical conditions and is continuously monitored by the operator during use. Qiona® can only be used as a cardiac tissue ablation solution pump. Qiona® has two overall operating modes. Throughout the ablation process, a small amount of normal saline solution is continuously delivered into the patient's circulation by the LOW flow (low flow) function of Qiona® which can be adjusted. This function is used to keep the catheter tip open and thus prevent clotting and occlusion of the catheter tip opening. When high-frequency current is used to ablate the cardiac conduction system in the heart muscle, Qiona® automatically or manually switches to a higher flow rate to cool the catheter tip. The Qiona® cardiac tissue ablation solution pump has a flushing function to clean the catheter connected to the ablation catheter and can use the maximum flow rate (about 50 ml/min) for this purpose.

Dates and status

Registration Date: Apr 10, 2024

About this record

Access comprehensive regulatory information for Myocardial Infusion Device Pump 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 2400455ĐKLH/BYT-HTTB and manufactured by Möller Medical GmbH. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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