High-level Disinfectant Solution for Medical Equipment - Vietnam Registration 2400931ĐKLH/BYT-HTTB
Access comprehensive regulatory information for High-level Disinfectant Solution for Medical Equipment 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 2400931ĐKLH/BYT-HTTB and manufactured by ACCUPAC, LLC. The authorized representative in Vietnam is CÔNG TY TNHH SẢN PHẨM KHỬ TRÙNG CAO CẤP VIỆT NAM.
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Device Details
Registration Details
2400931ĐKLH/BYT-HTTB
000.00.04.G18-211105-0003
AERO-OPA ortho-Phthalaldehyde Solution
25410
Technical Details
The AERO-OPA ortho-Phthalaldehyde Solution is a high-level disinfectant for reprocessing heat-sensitive medical devices (endoscopes) that cannot be subjected to conventional sterilization methods and must be used in accordance with the Instructions for Use. The AERO-OPA solution is intended for use with AEROFLEX AER and the AUTOSURE MRC Screen. This product must not be used manually. Medical devices (endoscopes) reprocessed in the AERO-OPA solution must be cleaned first according to the cleaning protocol or established cleaning standard.
Dates and Status
Jul 21, 2024