Donnevie Medical Technology (Shanghai) Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 1 device type, 2 products catalogued, 4 clearances.
Donnevie Medical Technology (Shanghai) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Microtools, Assisted Reproduction (Pipettes), Exempt. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
1device type
2products catalogued under its own name
4510(k) clearances
Registration
| Registered name | DONNEVIE MEDICAL TECHNOLOGY (SHANGHAI) CO.LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015739059 |
| FEI number | 3015739059 |
| DUNS | 554479334 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 东蕴医疗科技（上海）有限公司 |
|---|---|
| Unified social credit code | 91310115MA1K3RU75Y |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Suite 101, 201 & 301,Bld 1, 138 Xinjun Ring, Minhang District |
| Postal code | 201114 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Microtools, Assisted Reproduction (Pipettes), Exempt | Class 2 | Micromanipulation Pipettes; Dewin Biopsy Pipette(D-BIOX); Dewin Holding Pipette(D-HOLD); Dewin Injection Pipette(D-ICSI), Micromanipulation Pipettes;Dewin Assisted Hatching Pipette(D-HATC);Dewin Zona Drilling Pipette(D-HPZD), Micromanipulation Pipettes;Dewin Denuding Pipette(D-DENU) | 2019 | 8 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251637 | 2025-08-27 | MQL | Traditional | This company |
| K242561 | 2025-04-10 | MQL | Traditional | This company |
| K231370 | 2023-08-04 | MQL | Traditional | This company |
| K212426 | 2022-06-16 | MQL | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.