FDA.reportPublic FDA data

BIO PROTECH YANTAI INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108059413010805941BIO PROTECH YANTAI INC1N2027-01-0150 - 9, Beijingzhong Road Development Zone Yantai Shandong CN 264000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1686191946204251K192035EvaQMax Smoke Evacuation SystemFYD2019-08-29
1686191411977017K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesGXY2016-03-21
1686191566551344K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesIKT2016-06-03
1686191164587280K143103PROPENCIL Smoke PencilGEI2015-07-16
1686191405272912K142099CUTANEOUS ELECTRODESGXY2014-11-17
1686191970780211K111270REUSABLE STIMULATING ELECTRODESGXY2011-09-13
1686191011095965K100246MAX-IF1000LIH2010-11-24
1686191080017306K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CGEI2009-11-24
1686191972035945K092732PROPENCIL ESU PENCILGEI2009-11-25
1686191463017031K091248MAXEMS, MODELS 1000 AND 2000IPF2009-11-30
1686191920956911K083494ULTIMA FIVEGZJ2009-01-06
1686191059444266K083148TELECTRODE WET GEL ECG ELECTRODEDRX2008-11-07
1686192043442874K073438PROSTIM 1000/2000GZJ2008-02-07
1686191164406684K073360PROPLATEGEI2007-12-19
1686191635032963K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20DRX2005-12-14
1686191031991674K042301PROTENS ELECTRODEGXY2004-09-03
1686192038139356K040784PROTAB ECG TABB ELECTRODEDRX2004-04-07
1686191060557661K030375SOFT-TOUCH TENS ELECTRODEGXY2003-05-05
1686191896382484K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILEDRX2002-11-07
1686191233608380
1686191973028628
1686191251810964

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXY102016-03-21
GEI82015-07-16
DRX82008-11-07
GZJ42009-01-06
FYD22019-08-29
IKT22016-06-03
LIH22010-11-24
IPF22009-11-30