Berpu Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles510(k)Feb 1, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 1, 2024
Insulin Syringes without needle510(k)Nov 3, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 3, 2022
Safety Insulin Syringes510(k)Aug 23, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 23, 2022
Syringe with permanently attached needle510(k)Jul 21, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 21, 2022
Sterile Hypodermic Syringes for Single Use510(k)May 12, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 12, 2022
Safety Pen Needle for Single Use, Insulin Pen Needles510(k)Apr 29, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 29, 2022