Medical Device Manufacturer · CN , Shanghai

Donnevie Medical Technology (Shanghai) Co. , Ltd.

4 submissions · 4 cleared · Since 2022
4
Total
4
Cleared
0
Denied

Donnevie Medical Technology (Shanghai) Co. , Ltd. — FDA 510(k) Submissions

Donnevie Medical Technology (Shanghai) Co. , Ltd. has submitted 4 FDA 510(k) premarket notifications since 2022, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Reproductive . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
K251637 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2025 90d
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K242561 · MQL Media, Reproductive · Obstetrics & Gynecology
Apr 2025 225d
Dewin Blastocyst Medium (with HSA and without HSA)
K231370 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2023 84d
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
K212426 · MQL Media, Reproductive · Obstetrics & Gynecology
Jun 2022 316d
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