Vietnam MOH registration 2403534ĐKLH/BYT-HTTB

Cough and cold

VN: Tay dao hàn mạch

Vietnam·Risk Class TBYT Loại C·LigaSure Exact Dissector Nano-coated·Covidien·Registered Nov 14, 2024

Registration details

Analysis ID: 2403534ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210530-0004
Product Type: LigaSure Exact Dissector Nano-coated
Product Code: LF2019

Company information

Manufacturer: Covidien
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH MEDTRONIC VIỆT NAM

Technical details

Intended Use: The LigaSure™ Hemostat is a high-end bipolar instrument used in open surgery for hemostasis and vascular dissection, tissue and lymph node coagulation. The LigaSure™ Hemostat can be used for blood vessels (arteries or veins) up to 7mm in diameter. The product is indicated for use in general surgery and specialized surgeries such as urology, thoracic surgery, aesthetic surgery, and gynecology. These surgeries are not limited to bowel resection, cholecystectomy, etc. This instrument is also indicated for open otolaryngology procedures in adults (thyroidectomy, neck dissection, tonsillectomy, etc.) by coagulating and dividing blood vessels, lymph nodes, and tissues 2-3mm away from heat-sensitive structures such as nerves or parathyroid glands. Ligasure has not been proven effective in fallopian tube occlusion for birth control. Therefore, Ligasure should not be used in these procedures.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Cough and cold in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403534ĐKLH/BYT-HTTB and manufactured by Covidien. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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