510(k) K212426

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) by Donnevie Medical Technology (Shanghai) Co. , Ltd. — Product Code MQL

K212426 is an FDA 510(k) premarket notification submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. for the device "Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])". The FDA issued a decision of Substantially Equivalent on June 16, 2022. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Donnevie Medical Technology (Shanghai) Co. , Ltd. has at least 3 other 510(k) clearances on record.