Donnevie Medical Technology (Shanghai) Co., Ltd.
Shanghai, CN
Donnevie Medical Technology (Shanghai) Co. , Ltd. appears in FDA device records in Shanghai, CN. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 4
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 4 510(k) clearances for Donnevie Medical Technology (Shanghai) Co., Ltd. between 2022 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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]) | MQL | Substantially Equivalent | |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | MQL | Substantially Equivalent | |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | MQL | Substantially Equivalent | |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) | MQL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain