High-level Disinfectant Solution for Medical Equipment
Vietnam·Risk Class TTBYT Loại C·AERO-OPA ortho-Phthalaldehyde Solution·ACCUPAC, LLC·Registered Jul 21, 2024- Analysis ID
- 2400931ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211105-0003
- Product Type
- AERO-OPA ortho-Phthalaldehyde Solution
- Product Code
- 25410
- Manufacturer
- ACCUPAC, LLC
- Manufacturer Country
- UNITED STATES
- Product Owner
- ASP International GmbH Zweigniederlassung Zug
- Authorized Representative
- CÔNG TY TNHH SẢN PHẨM KHỬ TRÙNG CAO CẤP VIỆT NAM
- Intended Use
- 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.
- Registration Date
- Jul 21, 2024
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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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