Guangzhou Improve Medical Instruments Co., Ltd. is one of 2194 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Guangzhou Improve Medical Instruments Co., Ltd. - FDA 510(k) Cleared ...
Recent clearances: IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle, IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
2
Total
2
Cleared
0
Denied
Guangzhou Improve Medical Instruments Co., Ltd. specializes in blood collection and clinical laboratory diagnostic devices. The company operates with a manufacturing facility in Shanghai, China.
The company has received 2 FDA 510(k) clearances from 2 total submissions between 2010 and 2016. Its cleared devices focus on chemistry devices and blood collection systems, including multi-sample needles, blood collection sets, and tube additives for specimen management.
The company is currently inactive in the FDA 510(k) program, with no submissions recorded since 2016. This profile serves as a historical regulatory record. Explore the device names, product codes, and clearance dates in the database for complete submission details.
510(k) submissions have been managed by Mid-Link Consulting Co, Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Guangzhou Improve Medical Instruments Co., Ltd.
2 devices