Artificial Lung
Vietnam·Risk Class TTBYT Loại C·BRIZIO- MEMBRANE OXYGENATOR AND VENOUS RESERVOIR WITH INTEGRATED CARDIOTOMY FILTER·NIPRO MEDICAL Ltda·Registered Aug 30, 2024- 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
- Manufacturer
- NIPRO MEDICAL Ltda
- Manufacturer Country
- BRAZIL
- Product Owner
- NIPRO MEDICAL Ltda
- Authorized Representative
- CÔNG TY TNHH NIPRO SALES VIỆT NAM
- 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.
- Registration Date
- Aug 30, 2024
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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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