Bain Medical Equipment (Guangzhou) Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Bain Medical Equipment (Guangzhou) Co., Ltd. - FDA 510(k) Cleared Dev...
Recent clearances: NovaLine Tubing Set for Hemodialysis (BL 124), NovaLine SP-C35 Transducer Protector (956007), DORA Disposable A.V. Fistula Needle Sets
7
Total
7
Cleared
0
Denied
Bain Medical Equipment (Guangzhou) Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Guangzhou, CN.
Latest FDA clearance: May 2026. Active since 2017. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mid-Link Consulting Co, Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Bain Medical Equipment (Guangzhou) Co., Ltd.
7 devices
Cleared
May 15, 2026
NovaLine Tubing Set for Hemodialysis (BL 124)
Gastroenterology & Urology
287d
Cleared
Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
Gastroenterology & Urology
158d
Cleared
Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
Gastroenterology & Urology
200d
Cleared
Mar 10, 2021
NovaLine Tubing Sets for Hemodialysis
Gastroenterology & Urology
246d
Cleared
Feb 25, 2021
Surgical Masks
General Hospital
86d
Cleared
Jul 20, 2017
DORA Disposable A.V. Fistula Needle Sets
Gastroenterology & Urology
262d
Cleared
Jun 16, 2017
DORA Tubing Sets for Hemodialysis
Gastroenterology & Urology
373d