Data / Medical devices / China / Baisheng Medical Co.,ltd.
Baisheng Medical Co.,ltd.: FDA-registered device maker in JIANGMEN Guangdong, China, 9 510(k) clearances
Baisheng Medical Co.,ltd. is registered with the FDA (registration 3007748793) in JIANGMEN Guangdong, China. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007748793
- Address
- No.11, Fusheng Road, Xinhui District, JIANGMEN Guangdong, China, 529100
- Owner or operator
- BAISHENG MEDICAL CO., LTD (10028995)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 8, 2009
- Registered through
- 2026
- Brand names listed
- Disposable skin staplers, Electrocardiograph Electrode, Electrosurgical Cutting and Coagulation Device and Accessories, Electrosurgical Generator, Electrosurgical Pads, Electrosurgical Pencils, Electrosurgical generator, HALYARD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | 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 |
|---|---|---|---|---|---|---|
| August 13, 2025 | K250841 | Electrotherapy Electrodes | GXY | Substantially Equivalent | Baisheng Medical Co., Ltd. | accessdata.fda.gov |
| June 19, 2025 | K251235 | Electrosurgical Pads | GEI | Substantially Equivalent | Baisheng Medical Co., Ltd. | accessdata.fda.gov |
| January 8, 2024 | K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | GEI | Substantially Equivalent | Baisheng Medical Co., Ltd. | accessdata.fda.gov |
| November 23, 2022 | K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) | GEI | Substantially Equivalent | Baisheng Medical Co., Ltd. | accessdata.fda.gov |
| November 24, 2020 | K200931 | RF Surgical Generator | GEI | Substantially Equivalent | Fulwell, LLC | accessdata.fda.gov |
| June 13, 2019 | K183564 | Electrosurgical Generator | GEI | Substantially Equivalent | Fulwell, LLC | accessdata.fda.gov |
| January 30, 2017 | K162034 | OBS Electrosurgical Generator (Model: OBS-350A) | GEI | Substantially Equivalent | Baisheng Medical Co., Ltd. | accessdata.fda.gov |
| November 3, 2010 | K102372 | OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB | GEI | Substantially Equivalent | Jiangmen City Xinhui Baisheng Medical Equipment CO | accessdata.fda.gov |
| December 1, 2009 | K092634 | OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF | GEI | Substantially Equivalent | Jiangmen City Xinhui Baisheng Medical Equipment CO | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Staple, Removable (Skin)
- All makers of Electrode, Cutaneous
- All makers of Electrode, Electrocardiograph
Updated August 13, 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.