Shinva Ande Healthcare Apparatus Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shinva Ande Healthcare Apparatus Co., Ltd. - FDA 510(k) Cleared Devic...
Recent clearances: Closed System Transfer Device, Disposable Sterile Syringe with permanently attached needle, Disposable Sterile Syringe with Safety Needle
6
Total
6
Cleared
0
Denied
Shinva Ande Healthcare Apparatus Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Zibo, CN.
Last cleared in 2022. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Shinva Ande Healthcare Apparatus Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Guangzhou Osmunda Medical Device Technical Service Co., Ltd. and Beijing Believe-Med Technology Service Co., Ltd..
FDA 510(k) Regulatory Record - Shinva Ande Healthcare Apparatus Co., Ltd.
6 devices
Cleared
Nov 23, 2022
Closed System Transfer Device
General Hospital
904d
Cleared
Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
General Hospital
274d
Cleared
Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
General Hospital
293d
Cleared
Jul 23, 2021
Disposable IV catheter
General Hospital
361d
Cleared
Sep 12, 2020
Disposable Enteral Feeding Syringe with Enfit Connector
Gastroenterology & Urology
257d
Cleared
May 31, 2017
Infusion Set for Single Use
General Hospital
254d