FDA.reportPublic FDA data

Sanmina

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10379981037998Sanmina, Huntsville, AL1N2026-01-0113000 Memorial Pkwy Sw HUNTSVILLE AL US 35803
30040165203004016520SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD.1N2026-01-015 Haroshet st. Koren Industrial Park Maalot-Tarshiha Northern IL 2101802
30041398193004139819Sanmina Ireland UC1N2026-01-01RATHEALY ROAD FERMOY, CORK Munster IE --
30042012753004201275SANMINA-SCI AB1N2026-01-01SVEDJEVAGEN 12 SJALEVAD Vasternorrland SE 89435
30065442993006544299Sanmina-SCI Systems de Mexico SA de CV1N2026-01-01Km 15.5 No. 29, Plant 06 Carr. Chapala-Guadalajara Jalisco MX 45640
30066068273006606827Sanmina-SCI Systems Singapore Pte. Ltd.1N2026-01-012 Chai Chee Drive SINGAPORE North East SG 469044
30078678381000161215Sanmina1N2026-01-012700 N 1st St SAN JOSE CA US 95134
30096092183009609218Sanmina Corporation1N2026-01-011201 W Crosby Rd Carrollton TX US 75006
30120143993012014399Sanmina-SCI India Pvt Ltd1N2026-01-01OZ-1, SIPCOT Hi-Tech SEZ Sriperumbudur Taluk, Kancheepuram District Oragadam Tamil Nadu IN 602 105

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
59601172199908K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderFRC2020-01-23
1421261360832130K191220Pure Vu SystemFDF2019-06-06
1421262038850123K190337ReWalk RestorePHL2019-06-03
59601902554597K183406CereLink ICP Monitor, CereLink ICP Extension CableGWM2019-01-11
1421261143592558K182149FFRangio SystemQEK2018-12-19
1071461497441648K173263Xpert Carba-RPOC2018-01-09
59581098602307K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerLCP2017-11-21
1071461676461127K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IVOCC2017-12-19
815761895544296K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA2017-10-23
815761003789424K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMCFR2017-10-19
59602023697674K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemMUD2016-12-16
59601787671218K160944ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW2016-08-31
59581042650090K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerLCP2015-09-25
59601684272776K150272Capnostream 35 Portable Respiratory MonitorCCK2015-07-17
59601201632576K143175AEx Generator; PlasmaBlade TGEI2014-12-31
59601486247480K143042SonarMed AirWave, Airway Monitoring SystemOQU2016-01-22
59601910753448K133973TEMPUS PRO WITH ENHANCED FEATURESQYW2014-08-14
59601126142995K133862ACCU-CHEK AVIVA PLUS SYSTEMNBW2014-04-29
2148821126142995K133862ACCU-CHEK AVIVA PLUS SYSTEMNBW2014-04-29
59601037300556K132561NURO NEUROMODULATION SYSTEMNAM2013-11-05
59601175654716K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMLFR2013-10-11
59601156309834K123754CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-12-21
1071461607051916K121515ISOLAZ 2 INTENSE PULSED LIGHT SYSTEMONF2012-06-05
59601942185009K113137GLUCOSE TEST SYSTEMNBW2012-01-06
1071461615546124K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMHQC2011-12-21
59601626648223K111353ACCU-CHECK COMBO SYSTEMLZG2012-07-17
815761613887431K103700ESSENTIAL MRI PATIENT MONITORDQA2011-03-15
59602072963335K101299ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEMLFR2011-09-21
59581035394335K092433DYSISHEX2011-03-10
59581591890593K060734FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)LKN2006-09-05
59581832448547BK110012
59601149790451
59601251458268
2176551440508462
2148821691540792
59602018388223
815761052735582
1421261062089471
59581098602307
1421261102376317
59601118352455
3110891120691170
815761127252673
59601135169170
3110891172199908
1421261201695809
815761242426070
1421261271191036
3110891276294955
59601298038433
1421261318895404
1071461320703148
815761337256956
1071461349579964
59621414074684
59621421205901
59601439269983
1421261442547648
1421261451101615
1421261499067637
1071461499075714
1421261558252712
2176551571929393
1421261588624859
815761605457986
59581612012712
1071461617753647
1421261637454170
1421261684272776
1071461701580717
1071461768162015
1421261781977583
2148821787671218
1071461791274165
2176551798833047
815761814282386
59581848688853
3110891851594615
1421261868418060
1421261899854726
1071461903388430
2176551959315212
2176551968737178
59621992154839
1071462050147142
3110892068301171

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW42016-08-31
LCP22017-11-21
LFR22013-10-11
FRC12020-01-23
FDF12019-06-06
PHL12019-06-03
GWM12019-01-11
QEK12018-12-19
POC12018-01-09
OCC12017-12-19
DHA12017-10-23
CFR12017-10-19
MUD12016-12-16
OQU12016-01-22
CCK12015-07-17
GEI12014-12-31
QYW12014-08-14
NAM12013-11-05
IYN12012-12-21
LZG12012-07-17
ONF12012-06-05
HQC12011-12-21
DQA12011-03-15
HEX12011-03-10
LKN12006-09-05