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ISO 13485:2016
Certificate No : No. Q5 104467 0001 Rev.00
Issuing authority : TUV SUD
Valid period : 2020/2/21 - 2020/2/21
Scope of Certificate: Design, Development, Production and Distribution of In-Vitro Diagnostic Kits for Fertility, Drug of Abuse and Infectious Diseases.
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CE
Issuing authority : Lotus BV
Valid period : 2020/3/10 - 2020/3/10
Our products meet applicable provisions of the follow the Directive and standards and fulfill the obligations imposed by Directive 98/79/EC.
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FDA
Certificate No : D379560
Issuing authority : FDA
Valid period : 2020/3/28 - 2020/3/28
Our products have completed the FDA Establishment Registration.
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