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Coloplast Hungary, KFT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30082622783008262278Coloplast Hungary, KFT1N2027-01-01Kerek utca 3 Tatabanya HU 2800

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1145701789041692K973070CONVEEN EASICATH SETEZD1997-11-06
1145701529422461K250270Luja SetEZD2025-04-17
1145701210400783K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)EZD2022-03-08
1145701232889649K191536Biatain Silicone AgFRO2020-02-21
1145701857604852K180258SpeediCath StandardGBM2018-10-25
1145702009461569K120828BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESFRO2012-04-05
1145701098151627K072808SPEEDICATH COMPACTGBM2007-11-09
1145702021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
1145701606593199K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
1145701923071866K023254SPEEDICATHGBM2003-01-27
1145701274346639
1145701283319432
1145701381517784
1145701787001776
1145701119879315
1145701215449625
1145701221578967
1145701306955084
1145701343180288
1145701414390695
1145701471863104
1145701476228152
1145701554983951
1145701710916042
1145702009417844

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EZD32025-04-17
FRO32020-02-21
GBM32018-10-25
EZP12006-10-13