FDA.reportPublic FDA data

BIO PROTECH, INC.

Matched from indexed company URL: Bio Protech, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97105823003514332BIO PROTECH, INC.1N2026-01-01151-3, Donghwagongdan-ro Munmak-eup Wonju-si Gangwon KR 26365
30044646723004464672BIO PROTECH USA, INC.1Y2026-01-0113311 166th St Ste A Cerritos CA US 90703
30108059413010805941BIO PROTECH YANTAI INC1N2026-01-0150 - 9, Beijingzhong Road Development Zone Yantai Shandong CN 264000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00817120020043Bio Protech - Generic (4848WCBZGN (48x48 sq. white cloth, NSCNS 35mil), 20 pcs/1 poly, No zipper714-730-9950bioprotechusa@gmail.com
00817120020340Bio Protech - 4848WCBZGN(NST) - 48mmx48mm Square Electrodes, White Fabric, Carbon, Plastic Zip Lock714-730-9950Bioprotechusa@gmail.com
00817120021088Bio Protech - SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hydrogel. 4 pcs per pack, 100 pcs per box, 1,000 pcs per case909-464-1464support@bioprotechusa.com
00817120021095Bio Protech - SG15G (Lifelines) - Lifelines OEM, Surface Electrodes, Square Shape, Ground Electrode, Cloth Backing, 42x60mm, Hydrogel. 1pc per pack, 25 pcs per box, 250 pcs per case909-464-1464support@bioprotechusa.com
00817120021101Bio Protech - NCS-1334 (Lifelines) - Lifelines OEM, Surface Electrodes, NCS Surface Electrode, Tabs, PET Film Backing Material, 13x24mm, Hydrogel, 100 pcs per pack, 500 pcs per box, 5,000 pcs per case909-464-1464support@bioprotechusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
203721946204251K192035EvaQMax Smoke Evacuation SystemFYD2019-08-29
1686191946204251K192035EvaQMax Smoke Evacuation SystemFYD2019-08-29
938131133743748K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXY2016-03-21
203721411977017K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXY2016-03-21
1686191411977017K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXY2016-03-21
203721566551344K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesIKT2016-06-03
1686191566551344K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesIKT2016-06-03
203721164587280K143103PROPENCIL Smoke PencilGEI2015-07-16
1686191164587280K143103PROPENCIL Smoke PencilGEI2015-07-16
938131368370118K143103PROPENCIL Smoke PencilGEI2015-07-16
1686191405272912K142099CUTANEOUS ELECTRODESGXY2014-11-17
203721405272912K142099CUTANEOUS ELECTRODESGXY2014-11-17
938131921171370K111270REUSABLE STIMULATING ELECTRODESGXY2011-09-13
1686191970780211K111270REUSABLE STIMULATING ELECTRODESGXY2011-09-13
203721970780211K111270REUSABLE STIMULATING ELECTRODESGXY2011-09-13
1686191011095965K100246MAX-IF1000LIH2010-11-24
203721011095965K100246MAX-IF1000LIH2010-11-24
938131111809873K100246MAX-IF1000LIH2010-11-24
1686191080017306K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CGEI2009-11-24
203721080017306K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CGEI2009-11-24
938131404639992K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CGEI2009-11-24
938131300548087K092732PROPENCIL ESU PENCILGEI2009-11-25
1686191972035945K092732PROPENCIL ESU PENCILGEI2009-11-25
203721972035945K092732PROPENCIL ESU PENCILGEI2009-11-25
938131172912699K091248MAXEMS, MODELS 1000 AND 2000IPF2009-11-30
1686191463017031K091248MAXEMS, MODELS 1000 AND 2000IPF2009-11-30
203721463017031K091248MAXEMS, MODELS 1000 AND 2000IPF2009-11-30
203721920956911K083494ULTIMA FIVEGZJ2009-01-06
1686191920956911K083494ULTIMA FIVEGZJ2009-01-06
1686191059444266K083148TELECTRODE WET GEL ECG ELECTRODEDRX2008-11-07
203721059444266K083148TELECTRODE WET GEL ECG ELECTRODEDRX2008-11-07
938131525668702K083148TELECTRODE WET GEL ECG ELECTRODEDRX2008-11-07
938131366387053K073438PROSTIM 1000/2000GZJ2008-02-07
203722043442874K073438PROSTIM 1000/2000GZJ2008-02-07
1686192043442874K073438PROSTIM 1000/2000GZJ2008-02-07
1686191164406684K073360PROPLATEGEI2007-12-19
203721164406684K073360PROPLATEGEI2007-12-19
938131552295369K073360PROPLATEGEI2007-12-19
938131409253925K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20DRX2005-12-14
203721635032963K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20DRX2005-12-14
1686191635032963K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20DRX2005-12-14
1686191031991674K042301PROTENS ELECTRODEGXY2004-09-03
203721031991674K042301PROTENS ELECTRODEGXY2004-09-03
938131037107126K042301PROTENS ELECTRODEGXY2004-09-03
938131593782101K040784PROTAB ECG TABB ELECTRODEDRX2004-04-07
203722038139356K040784PROTAB ECG TABB ELECTRODEDRX2004-04-07
1686192038139356K040784PROTAB ECG TABB ELECTRODEDRX2004-04-07
203721060557661K030375SOFT-TOUCH TENS ELECTRODEGXY2003-05-05
1686191060557661K030375SOFT-TOUCH TENS ELECTRODEGXY2003-05-05
938131831192159K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILEDRX2002-11-07
1686191896382484K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILEDRX2002-11-07
203721896382484K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILEDRX2002-11-07
1686191233608380
203721233608380
1686191973028628
203721973028628
203721251810964
1686191251810964

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXY232016-03-21
GEI202015-07-16
DRX202008-11-07
GZJ92009-01-06
LIH52010-11-24
IPF52009-11-30
FYD42019-08-29
IKT42016-06-03

PMN#

GUDID#

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