Data / Medical devices / China / Bain Medical Equipment(guangzhou) Co., Ltd.
Bain Medical Equipment(guangzhou) Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 5 510(k) clearances
Bain Medical Equipment(guangzhou) Co., Ltd. is registered with the FDA (registration 3013217742) in Guangzhou Guangdong, China. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 15, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013217742
- Address
- No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District, Guangzhou Guangdong, China, 510760
- Owner or operator
- Bain Medical Equipment(Guangzhou) Co., Ltd. (10059567)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 12, 2021
- Registered through
- 2026
- Brand names listed
- NovaLine SP-C35 Transducer Protector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Fistula | FIE | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Protector, Transducer, Dialysis | FIB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 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 15, 2026 | K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | FJK | Substantially Equivalent | Bain Medical Equipment (Guangzhou) Co., Ltd. | accessdata.fda.gov |
| June 28, 2024 | K240164 | NovaLine SP-C35 Transducer Protector (956007) | FIB | Substantially Equivalent | Bain Medical Equipment (Guangzhou) Co., Ltd. | accessdata.fda.gov |
| April 8, 2022 | K213015 | DORA Disposable A.V. Fistula Needle Sets | FIE | Substantially Equivalent | Bain Medical Equipment (Guangzhou) Co., Ltd. | accessdata.fda.gov |
| March 10, 2021 | K201866 | NovaLine Tubing Sets for Hemodialysis | FJK | Substantially Equivalent | Bain Medical Equipment (Guangzhou) Co., Ltd. | accessdata.fda.gov |
| June 16, 2017 | K161582 | DORA Tubing Sets for Hemodialysis | FJK | Substantially Equivalent | Bain Medical Equipment (Guangzhou) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of Needle, Fistula
- All makers of Protector, Transducer, Dialysis
Updated May 15, 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.