Hantech Medical Device Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Hantech Medical Device Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010), Disposable Insulin Pen Needle, Disposable Insulin Syringe
5
Total
5
Cleared
0
Denied
Hantech Medical Device Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in Ningbo, CN.
Last cleared in 2023. Active since 2022. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Hantech Medical Device Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Hantech Medical Device Co., Ltd.
5 devices
Cleared
Sep 27, 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003,...
General Hospital
139d
Cleared
Apr 06, 2023
Disposable Insulin Pen Needle
General Hospital
209d
Cleared
Mar 06, 2023
Disposable Insulin Syringe
General Hospital
181d
Cleared
Sep 01, 2022
Disposable Medical Masks
General Hospital
147d
Cleared
Aug 23, 2022
Disposable Medical Safety Hypodermic Needle
General Hospital
174d