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Donnevie Medical Technology (Shanghai) Co. , Ltd.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest FDA decision2025-08-27
TypeNumberDevice NameCodeDateActions
510(k) K251637 Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])MQL2025-08-27 View
510(k) K242561 Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL2025-04-10 View
510(k) K231370 Dewin Blastocyst Medium (with HSA and without HSA)MQL2023-08-04 View
510(k) K212426 Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])MQL2022-06-16 View