FDA.reportPublic FDA data

MANI, INC. (HANAOKA FACTORY)

Matched from indexed company URL: MANI, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044670193004467019MANI, INC. (HANAOKA FACTORY)1N2026-01-01151 HANAOKA, OOAZA, TAKANEZAWA SHIOYA Tochigi JP 329-1207
30075847113007584711MANI MEDICAL GERMANY GmbH1N2026-01-01Hertha-Sponer-Strasse 2 Rosbach Hesse DE 61191
30077915733007791573Mani Hanoi Co. Ltd1N2026-01-01Vang Residential group Van Xuan Ward, Thai Nguyen Province VN -
30103982153010398215MANIFATTURA CI-ZETA SRL1N2026-01-01via Luigi Fassati, 11 Passirano Brescia IT 25050
30108060393010806039Manish MIttal1N2026-01-011063 Selma Ln Naperville IL US 60540
30142769723014276972Mani Hanoi Co. Ltd Pho Yen 2 Factory1N2026-01-01Plot CN5, Diem Thuy Industrial Zone - Area A Pho Yen Ward, Thai Nguyen Province VN -
30166702563016670256Mani Shanmugham1N2026-01-0114 Penn Plaza Floor 9 225 West 34th Street New York City NY US 10122
30346015483034601548MANI MEDICAL AMERICA, INC.1Y2026-01-0121250 Hawthorne Blvd. Suite 500 Torrance CA US 90503
30107817063010781706MANIX CO., LTD.1N2020-04-251232, Seodong-daero Poseung-eup Pyeongtaek-si Gyeonggido KR 451824

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2429521566222629K232588Aluna 2BZH2024-11-25
2429521451370562K230214Huma RPM (RPM)MWI2023-06-02
978061535441240K152471CAPO BULK FILLEBF2016-08-04
978061075030042K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowEBF2016-10-24
978061801892960K133268TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANSEBG2015-02-12
2121741303409636K053638MANI NEEDLE & SUTURE PACK (SILK)GAP2006-05-19
1049321303409636K053638MANI NEEDLE & SUTURE PACK (SILK)GAP2006-05-19
1049321900732372K053636MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)GAM2006-03-14
2121741900732372K053636MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)GAM2006-03-14
978061685216956K052189REVENEER CERAMIC REPAIR SYSTEMKLE2005-10-17
978061298472186K052073FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000EBI2005-10-26
978061250569025K051050SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092KLE2005-06-29
1049321032999213
2429521210906437
1049321273313593
1804821282258514
1049321396978046
1049321506545091
1804821838734637
1686341845674012
1049321882181857
1049321883542784
1049321979959084
1686342039381984
1049322042492933
2121742042492933
2121741004978553
1049321004978553
1804821019784500
3480111037330791
1049321037330791
978061058079261
3480111070763611
1049321070763611
1049321113460255
978061169912002
978061185931405
1049321257187544
1049321280940656
2121741303409636
1049321303409636
1049321306415658
2429521370940339
3108651406828085
1049321417301487
1049321429055491
3108651484887864
1049321547009747
1049321588135999
1049321596947317
2121741646270225
1049321646270225
2121741663866096
1049321663866096
2121741670789827
3108651708545030
1049321790833477
2121741900732372
1049321900732372
978061935872938
978062050078099
3108652051678429

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF22016-10-24
GAP22006-05-19
GAM22006-03-14
KLE22005-10-17
BZH12024-11-25
MWI12023-06-02
EBG12015-02-12
EBI12005-10-26

PMN#

GUDID#

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