FDA.reportPublic FDA data

FOREMOUNT ENTERPRISE CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96158263002973578FOREMOUNT ENTERPRISE CO., LTD.1N2020-04-25No.17, Alley 15, Lane 5,Shenan Street Shengang District Taichung City Taichung - Municipality TW 429

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
193041463227949K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerBTM2018-05-11
193041885540776K143615Antistatic Compact Space ChamberNVP2016-01-26
193041340504437K123469POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILELZA2013-02-19
193041115220509K122252SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUSNVP2013-11-13
193041337727338K121770HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZERCAF2013-04-17
193041184091169K121747FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKSBZD2013-03-14
193041860075550K042727POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201ACBP2005-03-18
193041526457561K032878KUNG SHIN, HMEF SK203CAH2004-09-20
193041052918282
193041160175694
193041163053258
193041246501193
193041359749980
193041405390798
193041479155024
193041573594430
193041585269244
193041635520485
193041707999690
193041752707318
193041756515880
193041818922984
193041849773027
193041923445577
193041938187649
193041972142229

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NVP22016-01-26
BTM12018-05-11
CAF12013-04-17
BZD12013-03-14
LZA12013-02-19
CBP12005-03-18
CAH12004-09-20

PMN#

GUDID#

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