FDA.reportPublic FDA data

SURE-TECH DIAGNOSTIC ASSOCIATES, INC.

Matched from indexed company URL: Sure Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19380951938095SURE-TECH DIAGNOSTIC ASSOCIATES, INC.1N2026-01-0112115 Tesson Ferry Professional Ctr Saint Louis MO US 63128
80406413002808272SURETEX, LTD.1N2026-01-0131/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai Amphur Phunphin Surat Thani TH 84130
30038953293003895329SURESTEP, LLC1N2026-01-0117530 DUGDALE DR South Bend IN US 46635
30055756043005575604SURETEK MEDICAL1N2026-01-0125-B MAPLE CREEK CIRCLE GREENVILLE SC US 29607
30109098763010909876Surefire Medical, Inc.1N2026-01-016272 W 91st Ave Westminster CO US 80031
30135361883013536188Suresh Persaud1N2026-01-0171 Cherry Hill Drive Beverly MA US 01915
30167592353016759235SURE COUNT SURGICAL, LLC1N2026-01-012049 Century Park East, #2600 Los Angeles CA US 90067
30186859783018685978SUREPULSE MEDICAL LIMITED1N2026-01-01Medicity D6 Thane Road Nottingham Nottinghamshire GB NG90 6BH
30206898443020689844Suresh Persaud1N2026-01-0171 Cherry Hill Drive Beverly MA US 01915
30219858293021985829SURE RETRACTORS LTD1N2026-01-01Suite 10, Dunswood House, 1 Dunswood Road, Cumbernauld Glasgow North Lanarkshire GB G67 3EN
30246823013024682301SUREAX MEDICAL, CORPORATION1N2026-01-0111107 Roselle St 237 San Diego CA US 92121
00SURE BIO TECH5N2020-04-25No.369 Hedong Road, Hi-tech Industrial Development Zone Qingdao City Shandong CN 266112
30107613193010761319Surefit Shoes1N2020-04-254050 NW 126th ave suite 110 Coral Springs FL US 33065
30157175503015717550Sure, Inc.1N2020-04-2544075 Pipeline Plaza Suite 320 Ashburn VA US 20147
30165661063016566106SUREWIN IMPORT & EXPORT CO. LTD1N2020-04-25807, 163 Guobanbeili Dongfu Town Haicang District Xiamen Fujian CN 361027

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
148401138234726K992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABELHIS1999-08-19
148401716416883K983518LIFESTYLES XTRA PLEASUREHIS1999-07-06
148401905371617K942858LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)HIS1995-05-18
148401584988885K941258LATEX CONDOMHIS1995-12-06
148401351408332K940046NON-LUBRICATED CONDOMHIS1995-01-30
148401431160044K931077LATEX PROPHYLACTIC RUBBER CONTRACEPTIVEHIS1994-09-14
338771917298870K892241FETAL HEMOGLOBINGHQ1989-05-17
3101892020950073K250203SureAx-Guide™DQX2025-10-17
1752361111752054K233858TriSalus TriGuideTM Guiding CatheterDQY2023-12-27
148402025610773K232470Polyisoprene Extra Large CondomMOL2024-05-09
148401557565879K232279LifeStyles NRL Textured CondomHIS2023-10-05
148401958070332K23190845 Micron Polyisoprene CondomMOL2023-10-27
1752361606608250K230957TriSalus TriNav® LV Infusion SystemKRA2023-05-02
2879501597228278K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI2022-11-10
3062791597228278K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI2022-11-10
148401835841810K221243OFNat Lubricant (L15)NUC2022-09-30
148401379348404K213921Microthin Natural Rubber Latex CondomHIS2022-04-28
3062791148646869K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetKDI2021-08-12
2879501148646869K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetKDI2021-08-12
978461221644290K203134Hanger Cranial Band 3DMVA2022-07-01
3098031862635336K201887VS Newborn Heart Rate MonitorDQA2021-07-23
3062791119440373K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI2020-12-23
2879501119440373K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI2020-12-23
1752361361008226K193107TriSalus Infusion SystemKRA2019-12-03
148401249265503K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOL2018-12-06
2320661020770739K181672SureTouch Mobile Pressure Mapping SystemNKA2019-06-28
1752361218479967K180677Surefire Spark Infusion SystemDQO2018-04-03
148401091345752K172473LifeStyles® SKYN® Intimate Moments Personal LubricantNUC2017-12-15
148401443655914K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL2017-08-02
148401570379369K163107Lifestyles Zero Lubricated Latex Male CondomHIS2017-01-23
1752361119693266K162359Surefire Guiding CatheterDQY2016-09-21
148401122653663K160399Skyn Original Polyisoprene Lubricated Male CondomMOL2016-07-25
1752361516360787K140034SUREFIRE GUIDING CATHETERDQY2014-02-26
148401439165237K122720LIFESTYLES WARM LOVIN PERSONAL LUBRICANTNUC2013-02-22
148401257190651K122477LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANTNUC2013-02-19
148401665303601K122476LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANTNUC2013-03-07
148401411796964K122054LIFESTYLES NATURAL PERSONAL LUBRICANTNUC2013-02-14
1752361047234049K121677SUREFIRE HI-FLOW MICROCATHETERDQO2012-06-14
148401593888912K070800LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOMMOL2008-03-06
661651320111682K052692SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODESNUJ2006-05-10
661651703342287K052690SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTSNUJ2006-05-12
148401012219108K033076LIFESTYLES LIQUID PERSONAL LUBRICANTHIS2003-12-19
148401150621632K030176LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANTHIS2003-04-17
148401450043830K010371LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANTHIS2001-04-27
148401553319256K001883LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOMHIS2000-07-31
148401020560741K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOMHIS2000-04-19
2389471311726634
2562291491491541
2523021594330098
1752361694355383
1673721919340920
661651145362985
661651238332898
661651257751833
3028121262225466
3101891275149702
978461311016701
3101891325505104
338771363142445
978461412561704
978461485896485
661651560554441
661651567587742
661651585635914
978461635790222
661651717452783
661651744338287
661651853588330
661651922431717
2879501954097295
661652013559235
661652026301779
661652046972356

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIS142023-10-05
MOL62024-05-09
KDI62022-11-10
NUC62022-09-30
DQY32023-12-27
KRA22023-05-02
DQO22018-04-03
NUJ22006-05-12
DQX12025-10-17
MVA12022-07-01
DQA12021-07-23
NKA12019-06-28
GHQ11989-05-17

PMN#

GUDID#

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