Bio Protech Yantai Inc

FDA Filings

This page includes the latest FDA filings for Bio Protech Yantai Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010805941
• FEI Number: 3010805941
• Name: BIO PROTECH YANTAI INC
• Owner & Operator: BIO PROTECH, INC.
• Contact Address: 151-3, Donghwagongdan-ro Munmak-eup; Wonju-si KR-42 Gangweondo 26365 KR
• US Agent:
  • Judy Burton
  • Advena USA, LLC
  • 972 2435105
  • judy.burton@advenausa.com
• Importing Logistics Registration:
  • Importer: BIO PROTECH USA, INC.
  • Address: 13620 Benson Ave Unit A ; Chino, CA 91710 UNITED STATES
  • Phone: 1 909 4641464
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 50 - 9, Beijingzhong Road Development Zone; Yantai Shandong, 264000 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NKC BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMax ENDO	2020-01-27
PMN K192035 | FYD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMaxTrap	2019-08-30
PMN K192035 | FYD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMaxFit	2019-08-30
PMN K192035 | FYD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMaxAuto	2019-08-30
PMN K192035 | FYD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMax	2019-08-30
PMN K192035 | FYD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMax Filter	2019-08-30
PMN K142099 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROTENS Reusable Stimulating Electrodes	2017-01-25
PMN K152984 | IKT BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Monopolar Needle Electrodes	2016-06-07
PMN K152984 | IKT BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Hypodermic Needle Electrodes	2016-06-07
PMN K152984 | IKT BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable EP Needle Electrodes	2016-06-07
PMN K152984 | IKT BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Concentric Needle Electrodes	2016-06-07
PMN K152984 | GXZ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Monopolar Needle Electrodes	2016-06-07
PMN K152984 | GXZ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Hypodermic Needle Electrodes	2016-06-07
PMN K152984 | GXZ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable EP Needle Electrodes	2016-06-07
PMN K152984 | GXZ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Concentric Needle Electrodes	2016-06-07
PMN K153019 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable/Reusable Cup Electrodes	2016-03-24
PMN K153019 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Disposable Adhesive Surface Electrodes	2016-03-24
PMN K143103 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPENCIL Smoke Evacuation Pencil	2015-08-14
PMN K111270 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	REUSABLE STIMULATING ELECTRODE	2011-09-27
PMN K111270 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Innopatch Standard	2011-09-27
PMN K111270 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Innopatch Premium Silver	2011-09-27
PMN K111270 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Innopatch Economy	2011-09-27
PMN K111270 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	ELITE SILVER	2011-09-27
IKD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	TELECTRODE LEAD	2011-06-23
IKD BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Surface electrode Cbale	2011-06-23
PMN K100246 | LIH BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	MAX-IF	2010-12-27
PMN K100246 | LIH BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Innostim	2010-12-27
PMN K092761 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPLATE	2009-12-18
PMN K092732 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPENCIL	2009-12-18
PMN K091248 | IPF BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	MAXEMS	2009-12-18
PMN K091248 | IPF BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Innostim	2009-12-18
PMN K083148 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	WET-GEL	2009-01-13
PMN K073438 | GZJ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Ultima 3T	2008-02-11
PMN K073438 | GZJ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	MAXTENS 2200	2008-02-11
PMN K073438 | GZJ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	MAXTENS 2100	2008-02-11
PMN K073438 | GZJ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	MAXTENS 2000	2008-02-11
PMN K073438 | GZJ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	MAXTENS 1000	2008-02-11
PMN K073438 | GZJ BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	Innostim	2008-02-11
PMN K073360 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPLATE	2007-12-22
PMN K053011 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PRO-NEO	2007-12-04
PMN K042301 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROTENS	2007-12-04
PMN K040784 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROTAB	2007-12-04
PMN K040784 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	NEOTAB	2007-12-04
PMN K020003 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	TELECTRODE	2007-12-04

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019062823156	Pusan,South Korea -> Long Beach, California	TENS UNIT	59 CTN
2019053123002	Tsingtao,China (Mainland) -> Long Beach, California	ESU PENCILTENS ELECTRODETENS UNIT	400 CTN
2019012626356	Tsingtao,China (Mainland) -> Los Angeles, California	ESU PENCILTENS ELECTRODETENS UNIT	110 CTN
2019010321886	Tsingtao,China (Mainland) -> Los Angeles, California	TENS UNIT	175 CTN
2018121523563	Tsingtao,China (Mainland) -> Los Angeles, California	ESU PENCIL TENS	347 CTN
2018102729556	Tsingtao,China (Mainland) -> Los Angeles, California	ESU PENCIL ESU PLATE TENS TENS UNIT	5 PKG
2018082922456	Tsingtao,China (Mainland) -> Los Angeles, California	TENS ELECTRODE TENS UNIT	10 PKG