FDA.reportPublic FDA data

Genova Diagnostics

Matched from indexed company URL: GENO LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10558861000111208Genova Diagnostics1Y2026-01-0163 Zillicoa St Asheville NC US 28801
30058434183005843418GENORAY CO., LTD.1N2026-01-0160, Dunchon-daero 541beon-gil, Jungwon-gu Seongnam-si Gyeonggi KR 13212
30062230103006223010GENOSS Co., Ltd.1N2026-01-011201-1207, Gwanggyo business Center, 156, Gwanggyo-ro, Yeongtong-gu, Suwon-si Gyeonggi KR 16229
30075388763007538876GENORAY AMERICA INC.1Y2026-01-011220 N Simon Circle Unit B Anaheim CA US 92806
30081912513008191251GENOUROB1N2026-01-01Batiment 60 rue Henri Geret LAVAL Mayenne FR 53000
30130967693013096769Genolution Inc1N2026-01-01Rm 101-104, 301-305 , 120, Gaetbeol-ro Yeonsu-gu Inchecon Incheon KR 21999
30146558753014655875GENOBIO PHARMACEUTICAL CO., LTD.1N2026-01-012-1,2,3-101,No.2 Zone, Binlv Industrial Park,Binhai Tourism Area Tianjin CN 300480
30210476483021047648GENOMADIX INC1N2026-01-01340 Legget Drive Suite 180 Kanata (Ottawa) Ontario CA K2K1Y6

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
708192003124924K252229BELLIGER ACEOWB2026-04-02
708191904027645K250060GT300; GT300-COAS2025-10-08
708191809644571K243420HESTIAMUE2025-07-17
721891713426836K242386BluemoonEBZ2025-05-05
721891135498094K233885rainbow Paste Stain SEEIH2024-06-21
721891596085113K232174rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoEIH2024-02-23
708191768202573K232158GenX-CRMUH2023-09-13
708191319369154K232085DVAS (DVAS-M, DVAS-W)EHD2023-12-08
721891837177339K231480Bright MTA Sealer PlusKIF2023-07-28
708191517994959K230787Oscar 15 & Oscar 15iOWB2023-07-20
721891825747372K222688The TrustEKX2024-08-09
708191970973006K220423PAPAYA & PAPAYA PlusMUH2022-05-19
708191021722160K220392PAPAYA 3D & PAPAYA 3D PlusOAS2022-05-19
3197172035261322K220026Genomadix Cube CYP2C19 SystemNTI2023-03-21
721891761127526K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-PuttyELW2022-12-15
708192066806785K211780ZEN-2090 TurboOWB2022-03-09
708192039762685K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusOAS2020-09-16
721891892777185K200156Bright Low FlowEBF2020-10-27
721891276581857K200155Bright High FlowEBF2020-11-30
721891450082708K200153Bright Bond UniversalKLE2020-10-28
708191038926988K181943OSCAR (OSCAR Prime, OSCAR Classic)OWB2018-08-17
708191880791738K172810PORT-X IVEHD2018-03-07
708191133770868K172180OSCAR 15OWB2018-02-09
721891618010418K170596TN-BrushELB2017-09-11
721892071974137K160144rainbow LS BlockEIH2016-07-21
721891621124334K160079rainbow ShineEIH2016-11-10
721891835299708K153676OSTEON IIILYC2016-09-14
721891919895189K151846Rainbow LS PressingEIH2016-01-14
721891419045903K151844Rainbow ShadeEIH2015-10-16
721891514106966K151842Rainbow ShineEIH2016-01-14
721891455243908K151731Rainbow Paste StainEIH2016-04-15
721891868259522K151723Rainbow TransEIH2015-10-28
708191522616893K150354PAPAYA 3D PlusOAS2015-12-10
1029361587919095K150354PAPAYA 3D PlusOAS2015-12-10
708191093990189K141700PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2014-10-31
1029361512764894K141700PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2014-10-31
708191906969462K140041ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEMOWB2014-11-28
708191646304444K130419PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2013-11-06
1029361950880729K130419PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2013-11-06
708191876395656K130088PORT VIEW, DIGITAL X-RAY SENSOR SYSTEMMUH2013-07-18
708191383016167K120263VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2012-07-10
721891938071361K112716OSTEON IILYC2012-01-17
708191820503816K103182TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZ2011-01-14
708191193506412K103181ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZ2011-08-26
721891639491300K102307GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELSNPL2011-05-04
721891575994462K102015OSTEON, OSTEON SINUS, OSTEON LIFTINGLYC2010-11-19
721891705562028K092513RAINBOW BLOCKEIH2009-10-09
708191955014971K092171VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2010-04-26
708191033196143K091918ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PROOWB2009-10-07
708191458951327K063121PORTABLE X-RAY SYSTEM, MODEL PORT-X IIEHD2007-01-11
721891055910624K062834OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050LYC2007-04-24
721891070365992
1990781493507982
721891652388087
721891711856333
2476651837301262
2381371908493816
940531024383276
721891045587922
721891312502819
721891452893608

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EIH182024-06-21
MUH122023-09-13
OWB102026-04-02
LYC82016-09-14
OAS62025-10-08
EHD52023-12-08
EBF22020-11-30
ELB22017-09-11
LLZ22011-08-26
NPL22011-05-04
MUE12025-07-17
EBZ12025-05-05
EKX12024-08-09
KIF12023-07-28
NTI12023-03-21
ELW12022-12-15
KLE12020-10-28

NDC#

43 records. Showing 1-40. Next

PMN#

52 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next