Donnevie Medical Technology (Shanghai) Co. , Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Donnevie Medical Technology (Shanghai) Co. , Ltd. - FDA 510(k) Cleare...
Recent clearances: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA], Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit), Dewin Blastocyst Medium (with HSA and without HSA)
4
Total
4
Cleared
0
Denied
Donnevie Medical Technology (Shanghai) Co. , Ltd. has 4 FDA 510(k) cleared medical devices. Based in Shanghai, CN.
Latest FDA clearance: Aug 2025. Active since 2022. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Emergo Global Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Donnevie Medical Technology (Shanghai) Co. , Ltd.
4 devices
Cleared
Aug 27, 2025
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]
Obstetrics & Gynecology
90d
Cleared
Apr 10, 2025
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
Obstetrics & Gynecology
225d
Cleared
Aug 04, 2023
Dewin Blastocyst Medium (with HSA and without HSA)
Obstetrics & Gynecology
84d
Cleared
Jun 16, 2022
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without...
Obstetrics & Gynecology
316d