Baisheng Medical Co., Ltd.
Registered establishment in Jiangmen, Guangdong, China. 4 device types, 5 clearances.
Baisheng Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Electrode, Cutaneous, Staple, Removable (Skin) and 2 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | BAISHENG MEDICAL CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007748793 |
| FEI number | 3007748793 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 广东百生医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 914407057341275614 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Jiangmen |
|---|---|
| Province | Guangdong |
| Address | NO.11, FUSHENG ROAD, XINHUI DISTRICT |
| Postal code | 529100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | 2025 | 47 | |
| Electrode, Electrocardiograph | Class 2 | Electrocardiograph Electrode | 2012 | 33 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Halyard, Electrosurgical Pads, Medline Universal Grounding Pad, Electrosurgical Generator, Electrosurgical Cutting and Coagulation Device and Accessories, Electrosurgical Pencils | 2009 | 65 |
| Staple, Removable (Skin) | Class 1 | Disposable skin staplers | 2024 | 20 |
Clearances
5 clearances name Baisheng Medical Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250841 | 2025-08-13 | GXY | Traditional | This company |
| K251235 | 2025-06-19 | GEI | Traditional | This company |
| K233615 | 2024-01-08 | GEI | Traditional | This company |
| K221815 | 2022-11-23 | GEI | Traditional | This company |
| K162034 | 2017-01-30 | GEI | Traditional | This company |
| K200931 | 2020-11-24 | GEI | Traditional | Fulwell LLC |
| K183564 | 2019-06-13 | GEI | Traditional | Fulwell LLC |
| K102372 | 2010-11-03 | GEI | Traditional | Jiangmen City Xinhui Baisheng Medical Equipment Co |
| K092634 | 2009-12-01 | GEI | Traditional | Jiangmen City Xinhui Baisheng Medical Equipment Co |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 7,000 square meters |
|---|---|
| Main products | Electrosurgical generator, Electrosurgical pencil, Electrosurgical pad, ECG electrode |
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.