SMC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12255803012349753SMC Ltd.1N2026-01-0118 Independence Dr Devens MA US 01434
30064673003006467300SMC Medical Manufacturing Private Limited1N2026-01-0153/54, EPIP, WHITEFIELD BANGALORE Karnataka IN 560066
30093274453009327445SMC Costa Rica Division S.R.L.1N2026-01-01Building B48, Ave 0 Zona Franca Coyol El Coyol Alajuela CR 20101
30096272233009627223SMC, LLC.1N2026-01-01400 Enterprise Dr Nicholasville KY US 40356

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1323831890287775K982293PRESSURE TRANSDUCER AIRFLOW SENSORMNR1998-07-13
1323831257900039K960851THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSORBZQ1996-09-17
1323831389047565K940014PLM SENSOR, MODEL PLM1BZQ1994-11-10
1323831746254158K923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORBZQ1992-12-30
1323831073775865K913396CANNULA STYLE THERMOCOUPLESBZG1992-05-22
1323831600657997K113068REMSTAR AUTO A-FLEX HTBZD2011-12-16
1323831667956617K053063PRO-FLOW MULTIPURPOSE CANNULACCK2005-12-13
1323831263418082K040595ALICE 5OLZ2004-03-18
1323831792262023K013905MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORSMNR2002-04-22
1590651135364520
1551191437489644
1590651949176957
1551191149279001
1551191248617886
1551191332249970
1251851355433840
1323831478261014
1551191487043403
1251851487043403
1323831500999144
1323831523114918
1323831556693402
1251851611382031
1323831642184985
1323831703215374
1251851826194500

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZQ31996-09-17
MNR22002-04-22
BZD12011-12-16
CCK12005-12-13
OLZ12004-03-18
BZG11992-05-22

NDC#

PMN#

GUDID#

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