FDA.reportPublic FDA data

Essity HMS North America Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10395771039577Essity HMS North America Inc.1Y2026-01-017030 LOUISVILLE RD. BOWLING GREEN KY US 42101
25154442515444Essity HMS North America Inc.1Y2026-01-01804 Walker Rd DOVER DE US 19904
30065027463006502746Essity HMS North America Inc.1Y2026-01-012929 Arch St Philadelphia PA US 19104

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3498831776922476K990536O.B. TAMPONHEB1999-08-31
3498831789633623K974629O.B. APPLICATOR AND NON-APPLICATOR TAMPONSHEB1998-02-10
3498831983073244K180167Playtex Stella TamponsHEB2018-05-30
3498831923192189K132819PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONSHIL2013-10-09
3498831192177703K122603ONTEX AND OTHER PROPRIETARY NAMESHEB2012-12-19
3498831646920842K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSHIL2012-06-21
3498831348933164K111684PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDHIL2012-02-03
3498831410700922K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSHIL2008-01-17
3498831421929912K072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSHIL2007-12-12
3498831244434621K070745MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONSHIL2007-04-13
3498831294800657K060981PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONSHIL2006-05-09
3498831216622616K023789O.B. TAMPONSHEB2002-12-06
3498831078172449K022882MODIFICATION TO PLAYTEX TAMPONS #24002HIL2002-09-16
3498831948988922K020200PLAYTEX DEODORANT TAMPONS, MODEL 34802HIL2002-03-13
190611205782664
3498831267924382
190611316434957
3498831316434957
3498831515167783

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIL92013-10-09
HEB52018-05-30

NDC#