Data / Medical devices / China / Shanghai Berry Electronic Tech Co., Ltd.
Shanghai Berry Electronic Tech Co., Ltd.: FDA-registered device maker in Shanghai, China, 3 510(k) clearances
Shanghai Berry Electronic Tech Co., Ltd. is registered with the FDA (registration 3009241523) in Shanghai, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009241523
- Address
- Unit 104 1st Floor 7th Building No. 1188 Lianhang Road Minhang District, Shanghai, China, 201112
- Owner or operator
- Shanghai Berry Electronic Tech Co., Ltd. (10049547)
- Roles
- Manufacturer
- First device listed
- June 17, 2015
- Registered through
- 2026
- Brand names listed
- BC3500, BM1000, BM1000B, BM1000C, BM1000D, BM1000E, BM1300, BM20 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | 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 |
|---|---|---|---|---|---|---|
| September 25, 2025 | K250837 | Pulse Oximeter | DQA | Substantially Equivalent | Shanghai Berry Electronic Tech Co., Ltd. | accessdata.fda.gov |
| April 4, 2018 | K172141 | Pulse Oximeter | DQA | Substantially Equivalent | Shanghai Berry Electronic Tech Co., Ltd. | accessdata.fda.gov |
| April 13, 2015 | K142687 | Pulse Oximeter | DQA | Substantially Equivalent | Shanghai Berry Electronic Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Oximeter, Wellness
- All makers of Oximeter, Infrared, Sporting, Aviation
Updated September 25, 2025. 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.