Medical Device Manufacturer · CN , Wenzhou

Berpu Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2016

Recent clearances: Sterile Safety Hypodermic Needles for Single Use, Insulin Syringes without needle, Safety Insulin Syringes

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Berpu Medical Technology Co., Ltd. General Hospital ✕

9 devices
1-9 of 9
Cleared Feb 01, 2024
Sterile Safety Hypodermic Needles for Single Use
K232165 · FMI
General Hospital · 195d
Cleared Nov 03, 2022
Insulin Syringes without needle
K221045 · FMF
General Hospital · 209d
Cleared Aug 23, 2022
Safety Insulin Syringes
K220061 · MEG
General Hospital · 225d
Cleared Jul 21, 2022
Syringe with permanently attached needle
K213158 · FMF
General Hospital · 296d
Cleared May 12, 2022
Sterile Hypodermic Syringes for Single Use
K213811 · FMF
General Hospital · 156d
Cleared Apr 29, 2022
Safety Pen Needle for Single Use, Insulin Pen Needles
K212514 · FMI
General Hospital · 262d
Cleared Mar 12, 2019
Safety insulin needle for single use
K181447 · FMI
General Hospital · 284d
Cleared Aug 09, 2018
Self-destruction Safety Syringes for Single Use
K180417 · MEG
General Hospital · 175d
Cleared Dec 29, 2016
Disposable Insulin Syringe
K162180 · FMF
General Hospital · 147d
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