Vietnam MOH registration 2402077ĐKLH/BYT-HTTB

Low-Temperature Sterilization by Ethylene Oxide Gas

VN: Máy tiệt khuẩn nhiệt độ thấp bằng khí EO

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·3M Company·Registered Aug 27, 2024

Registration details

Analysis ID: 2402077ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210702-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: 3M Company
Manufacturer Country: Theo theo phụ lục
Product Owner: 3M Company
Authorized Representative: CÔNG TY TNHH 3M VIỆT NAM

Technical details

Intended Use: The sterilization of heat- and/or moisture-sensitive devices with the following cycles: Model GS5: [Cooling Cycle; Exposure time to EO gas (minutes): 270; Temperature (°C): 38; Concentration of EO gas (mg/L): 736; Relative humidity of the cycle (%RH): 40-80.]; Model GS5: [Heating Cycle; Exposure time to EO gas (minutes): 60; Temperature (°C): 55; Concentration of EO gas (mg/L): 736; Relative humidity of the cycle (%RH): 40-80.]; Model GS8: [Cooling Cycle; Exposure time to EO gas (minutes): 270; Temperature (°C): 38; Concentration of EO gas (mg/L): 759; Relative humidity of the cycle (%RH): 40-80.]; Model GS8: [Heating Cycle; Exposure time to EO gas (minutes): 60; Temperature (°C): 55; Concentration of EO gas (mg/L): 759; Relative humidity of the cycle (%RH): 40-80.] It is possible to sterilize rigid or flexible lumens, either singular or paired, together with non-lumen-bearing devices in any sterilization cycle of the sterilizer, provided that the corresponding parameters are in accordance with the instructions for each device. No sterilization cycle should exceed 20 lumens.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Low-Temperature Sterilization by Ethylene Oxide Gas 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 2402077ĐKLH/BYT-HTTB and manufactured by 3M Company. The authorized representative in Vietnam is CÔNG TY TNHH 3M VIỆT NAM.

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