GMP
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GMP

GMP
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Catalog excerpts

GMP-1

The Medical Device Manufacturer '• Yung Kang Medical Device Technology Co., Ltd. Address : No. 142, Sec. 3, Yunke Rd., Douliu City, Yunlin County, Taiwan (R.O.C.) QMS Number • QMS0799 QMS Number • QMS0799 Valid Until ' February 24, 2026 This Certificate is applicable to : 1 .Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Nonpowered, Single Patient, Portable Suction Apparatus, 2.Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Blood Specimen Collection Device (Sterile), 3.Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Vacuum-Powered Body Fluid Suction Apparatus, 4.Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Automated Blood Cell Separator (Sterile), 5.Design, Manufacture, Packaging, Labeling, Final Inspection and Release of Manual Surgical Instrument for General Use (Tissue Processor)(Sterile). The above-mentioned manufacturer, in accordance with Paragraph 2, Article 22 of the Medical Device Act, has been inspected and found to be in compliance with the Medical Device Quality Management System Regulations requirements (based on ISO 13485:2016). This certificate is hereby issued pursuant to Article 9 of the Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license. Food and Drug Administration Under the delegated authority of Dr. Tai-Yuan Chiu, M.H.Sci., Minister Ministry of Health and Welfare Republic of China (Taiwan)

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  1. ISO 13485

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