Artificial Lung - Vietnam Registration 2402320ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Artificial Lung 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 2402320ĐKLH/BYT-HTTB and manufactured by NIPRO MEDICAL Ltda. The authorized representative in Vietnam is CÔNG TY TNHH NIPRO SALES VIỆT NAM.

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2402320ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2402320ĐKLH/BYT-HTTB

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Device Details

Artificial Lung

VN: Phổi nhân tạo

Risk Class TTBYT Loại C

Registration Details

Analysis ID

2402320ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-230322-0011

Product Type

BRIZIO- MEMBRANE OXYGENATOR AND VENOUS RESERVOIR WITH INTEGRATED CARDIOTOMY FILTER

Product Code

BRZ+02000A, BRZ+02005A, BRZ+02345A, BRZ+12000A, BRZ+12005A, BRZ+012305A

Technical Details

Intended Use

The artificial lung is used for gas exchange and temperature regulation (thermoregulation) of the blood in the extracorporeal circulation and to remove air bubbles in open-heart surgery up to 6 hours. The surface in contact with the blood of the artificial lung is coated with the E8 polymer layer to prevent blood clotting adhesion.