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#

Nikzon Hemorrhoidal

Genomma Lab USA

Glycerin, Petrolatum, Phenylephrine hydrochloride, and Pramoxine hydrochloride

Lagicam

Genomma Lab USA, Inc.

Miconazole Nitrate

Silka

Genomma Lab USA, Inc.

Terbinafine Hydrochloride

Silka

Genomma Lab USA, Inc.

Terbinafine Hydrochloride

XRay DOL

Genomma Lab USA, Inc.

Camphor, Menthol, and Methyl Salicylate

XRay Pain Relief

Genomma Lab USA

MENTHOL, (plus)-, CAMPHOR, (-)-, and METHYL SALICYLATE

Tukol X-Pecto Miel

Genomma Lab USA, Inc.

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Tukol A

Genomma Lab USA, Inc.

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

43 records. Showing 1-40. Next

PMN#

HESTIA

2025-07-17

Genoray Co., Ltd.

52 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next