FDA Device Entity Profile: BIO PROTECH, INC.

Known Identifiers & Locations

FEI Numbers 3003514332, 3010805941

Owner Operator Numbers 9048345

Locations Covered Wonju-si Gangwon, KR; Yantai Shandong, CN

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3010805941	BIO PROTECH YANTAI INC	Yantai Shandong, CN	Manufacture Medical Device	View Details
9710582	BIO PROTECH, INC.	Wonju-si Gangwon, KR	Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K152984	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	2016-06-03	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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