Gemtier Medical (Shanghai), Inc. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Gemtier Medical (Shanghai), Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sterile Syringe with Fixed Safety Needle for Single Use, Medical Face Mask, Medical Face Mask
5
Total
5
Cleared
0
Denied
Gemtier Medical (Shanghai), Inc. has 5 FDA 510(k) cleared medical devices. Based in Shanghai, CN.
Last cleared in 2022. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Gemtier Medical (Shanghai), Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mid-Link Consulting Co, Ltd. and Shanghai Medical Business Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Gemtier Medical (Shanghai), Inc.
5 devices
Cleared
Mar 02, 2022
Sterile Syringe with Fixed Safety Needle for Single Use
General Hospital
191d
Cleared
Feb 04, 2021
Medical Face Mask
General Hospital
157d
Cleared
Feb 02, 2021
Medical Face Mask
General Hospital
169d
Cleared
Apr 10, 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single...
General Hospital
197d
Cleared
Dec 11, 2017
Safety Blood Collection Device for Single Use
General Hospital
315d