Bio Protech Inc

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

199290

DUNS 688460539

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

• Registration Number: 9710582
• FEI Number: 3003514332
• Name: Judy Burton
• 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
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3010 LBJ Frwy 12th Floor; Dallas, TX 75234 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NKC Judy Burton [BIO PROTECH, INC.]	EvaQMax ENDO	2020-01-27
NKC BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	EvaQMax ENDO	2020-01-27
PMN K192035 | FYD Judy Burton [BIO PROTECH, INC.]	EvaQMaxTrap	2019-08-30
PMN K192035 | FYD Judy Burton [BIO PROTECH, INC.]	EvaQMaxFit	2019-08-30
PMN K192035 | FYD Judy Burton [BIO PROTECH, INC.]	EvaQMaxAuto	2019-08-30
PMN K192035 | FYD Judy Burton [BIO PROTECH, INC.]	EvaQMax	2019-08-30
PMN K192035 | FYD Judy Burton [BIO PROTECH, INC.]	EvaQMax Filter	2019-08-30
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 K192035 Bio Protech, Inc.	EvaQMax Smoke Evacuation System	2019-08-29
PMN K142099 | GXY Judy Burton [BIO PROTECH, INC.]	PROTENS Reusable Stimulating Electrodes	2017-01-25
PMN K142099 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROTENS Reusable Stimulating Electrodes	2017-01-25
PMN K152984 | IKT Judy Burton [BIO PROTECH, INC.]	Disposable Monopolar Needle Electrodes	2016-06-07
PMN K152984 | IKT Judy Burton [BIO PROTECH, INC.]	Disposable Hypodermic Needle Electrodes	2016-06-07
PMN K152984 | IKT Judy Burton [BIO PROTECH, INC.]	Disposable EP Needle Electrodes	2016-06-07
PMN K152984 | IKT Judy Burton [BIO PROTECH, INC.]	Disposable Concentric Needle Electrodes	2016-06-07
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 Judy Burton [BIO PROTECH, INC.]	Disposable Monopolar Needle Electrodes	2016-06-07
PMN K152984 | GXZ Judy Burton [BIO PROTECH, INC.]	Disposable Hypodermic Needle Electrodes	2016-06-07
PMN K152984 | GXZ Judy Burton [BIO PROTECH, INC.]	Disposable EP Needle Electrodes	2016-06-07
PMN K152984 | GXZ Judy Burton [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 K152984 BIO PROTECH, INC.	Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, Disposable Hypodermic Needle Electrodes	2016-06-03
PMN K153019 | GXY Judy Burton [BIO PROTECH, INC.]	Disposable/Reusable Cup Electrodes	2016-03-24
PMN K153019 | GXY Judy Burton [BIO PROTECH, INC.]	Disposable Adhesive Surface Electrodes	2016-03-24
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 K153019 BIO PROTECH, INC.	Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes	2016-03-21
PMN K143103 | GEI Judy Burton [BIO PROTECH, INC.]	PROPENCIL Smoke Evacuation Pencil	2015-08-14
PMN K143103 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPENCIL Smoke Evacuation Pencil	2015-08-14
PMN K143103 BIO PROTECH, INC.	PROPENCIL Smoke Pencil	2015-07-16
PMN K142099 BIO PROTECH, INC.	CUTANEOUS ELECTRODES	2014-11-17
PMN K111270 | GXY Judy Burton [BIO PROTECH, INC.]	REUSABLE STIMULATING ELECTRODE	2011-09-27
PMN K111270 | GXY Judy Burton [BIO PROTECH, INC.]	Innopatch Standard	2011-09-27
PMN K111270 | GXY Judy Burton [BIO PROTECH, INC.]	Innopatch Premium Silver	2011-09-27
PMN K111270 | GXY Judy Burton [BIO PROTECH, INC.]	Innopatch Economy	2011-09-27
PMN K111270 | GXY Judy Burton [BIO PROTECH, INC.]	ELITE SILVER	2011-09-27
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
PMN K111270 BIO PROTECH, INC.	REUSABLE STIMULATING ELECTRODES	2011-09-13
IKD Judy Burton [BIO PROTECH, INC.]	TELECTRODE LEAD	2011-06-23
IKD Judy Burton [BIO PROTECH, INC.]	Surface electrode Cbale	2011-06-23
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 Judy Burton [BIO PROTECH, INC.]	MAX-IF	2010-12-27
PMN K100246 | LIH Judy Burton [BIO PROTECH, INC.]	Innostim	2010-12-27
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 K100246 BIO PROTECH, INC.	MAX-IF1000	2010-11-24
PMN K092761 | GEI Judy Burton [BIO PROTECH, INC.]	PROPLATE	2009-12-18
PMN K092761 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPLATE	2009-12-18
PMN K092732 | GEI Judy Burton [BIO PROTECH, INC.]	PROPENCIL	2009-12-18
PMN K092732 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPENCIL	2009-12-18
PMN K091248 | IPF Judy Burton [BIO PROTECH, INC.]	MAXEMS	2009-12-18
PMN K091248 | IPF Judy Burton [BIO PROTECH, INC.]	Innostim	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 K091248 BIO PROTECH, INC.	MAXEMS, MODELS 1000 AND 2000	2009-11-30
PMN K092732 BIO PROTECH, INC.	PROPENCIL ESU PENCIL	2009-11-25
PMN K092761 BIO PROTECH, INC.	PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C	2009-11-24
PMN K083148 | DRX Judy Burton [BIO PROTECH, INC.]	WET-GEL	2009-01-13
PMN K083148 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	WET-GEL	2009-01-13
PMN K083148 BIO PROTECH, INC.	TELECTRODE WET GEL ECG ELECTRODE	2008-11-07
PMN K073438 | GZJ Judy Burton [BIO PROTECH, INC.]	Ultima 3T	2008-02-11
PMN K073438 | GZJ Judy Burton [BIO PROTECH, INC.]	MAXTENS 2200	2008-02-11
PMN K073438 | GZJ Judy Burton [BIO PROTECH, INC.]	MAXTENS 2100	2008-02-11
PMN K073438 | GZJ Judy Burton [BIO PROTECH, INC.]	MAXTENS 2000	2008-02-11
PMN K073438 | GZJ Judy Burton [BIO PROTECH, INC.]	MAXTENS 1000	2008-02-11
PMN K073438 | GZJ Judy Burton [BIO PROTECH, INC.]	Innostim	2008-02-11
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 K073438 BIO PROTECH, INC.	PROSTIM 1000/2000	2008-02-07
PMN K073360 | GEI Judy Burton [BIO PROTECH, INC.]	PROPLATE	2007-12-22
PMN K073360 | GEI BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROPLATE	2007-12-22
PMN K073360 BIO PROTECH, INC.	PROPLATE	2007-12-19
PMN K053011 | DRX Judy Burton [BIO PROTECH, INC.]	PRO-NEO	2007-12-04
PMN K053011 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PRO-NEO	2007-12-04
PMN K042301 | GXY Judy Burton [BIO PROTECH, INC.]	PROTENS	2007-12-04
PMN K042301 | GXY BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	PROTENS	2007-12-04
PMN K040784 | DRX Judy Burton [BIO PROTECH, INC.]	PROTAB	2007-12-04
PMN K040784 | DRX Judy Burton [BIO PROTECH, INC.]	NEOTAB	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 Judy Burton [BIO PROTECH, INC.]	TELECTRODE	2007-12-04
PMN K020003 | DRX BIO PROTECH YANTAI INC [BIO PROTECH, INC.]	TELECTRODE	2007-12-04
PMN K053011 BIO PROTECH, INC.	PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20	2005-12-14
PMN K042301 BIO PROTECH, INC.	PROTENS ELECTRODE	2004-09-03
PMN K040784 BIO PROTECH, INC.	PROTAB ECG TABB ELECTRODE	2004-04-07
PMN K020003 BIO PROTECH, INC.	ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE	2002-11-07

Similar & Related FDA Registered Companies

• BIO PROTECH USA, INC.
• BIOPROTECH INC.

Related Finance Registrations

NCAGE Code	7415F	BIO PROTECH, INC
CAGE Code	7415F	BIO PROTECH, INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082844399	Pusan,South Korea -> Los Angeles, California	TENS UNIT	520 CTN
2020082465307	Pusan,South Korea -> Los Angeles, California	TENS UNIT	520 CTN
2020081142498	Pusan,South Korea -> Long Beach, California	TENS UNIT	425 CTN
2020080756312	Pusan,South Korea -> Long Beach, California	TENS UNIT	425 CTN
2020071351679	Pusan,South Korea -> Long Beach, California	TENS UNIT	559 CTN
2020062068352	Pusan,South Korea -> Long Beach, California	TENS UNIT	314 CTN
2020061583109	Pusan,South Korea -> Long Beach, California	TENS UNIT	713 CTN
2020061327363	Pusan,South Korea -> Long Beach, California	EVACUATION SYSTEM	1 PKG