Data / Medical devices / China / Fimilla (shanghai) Maternity & Baby Articles Co., Ltd
Fimilla (shanghai) Maternity & Baby Articles Co., Ltd: FDA-registered device maker in Shanghai, China, 4 510(k) clearances
Fimilla (shanghai) Maternity & Baby Articles Co., Ltd is registered with the FDA (registration 3020034975) in Shanghai, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated May 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020034975
- Address
- No. 65 Lane 3029 HuaXu Road, HuaXin Town QingPu District, Shanghai, China, Shanghai, China, 201700
- Owner or operator
- Fimilla (Shanghai) maternity & baby Articles Co., Ltd (10092151)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 9, 2024
- Registered through
- 2026
- Brand names listed
- Electric Breast Pump ( HL-3058 II Pro), Electric Breast Pump (F5055), Electric Breast Pump (Models HL-3058, F5112), Electric Breast Pump (Models HL-3060, F5113)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 13, 2026 | K254125 | Electric Breast Pump (HL-3058 II Pro) | HGX | Substantially Equivalent | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | accessdata.fda.gov |
| October 27, 2025 | K252630 | Electric Breast Pump (HL-3060, F5113) | HGX | Substantially Equivalent | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | accessdata.fda.gov |
| October 27, 2025 | K252629 | Electric Breast Pump (HL-3058, F5112) | HGX | Substantially Equivalent | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | accessdata.fda.gov |
| October 17, 2024 | K240218 | Electric Breast Pump (F5055) | HGX | Substantially Equivalent | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.