Low-Temperature Sterilization by Ethylene Oxide Gas - Vietnam Registration 2402077ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2402077ĐKLH/BYT-HTTB
000.00.04.G18-210702-0003
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Aug 27, 2024