FDA.reportPublic FDA data

Wellspect Healthcare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096326723009632672Wellspect Healthcare1N2026-01-01Aminogatan 1 Molndal Vastra Gotaland SE SE-43121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1498091394470311K896750LOFRIC(R), LOFRIC(R) CATH-KITKOD1990-08-06
1498091490072745K260999LoFric Elle ProEZD2026-04-24
1498091342854190K250659LoFric OrigoEZD2025-09-26
1498092000793886K223756SimPro™ Now, GentleCath™ HydrophilicEZD2023-05-04
1498091250812248K211212LoFric ElleEZD2022-02-17
1498091860913018K190977Navina Smart System, Navina Classic SystemKNT2019-11-22
1498091287105071K170487Navina Classic SystemKNT2017-09-11
1498091495111785K123751LOFRIC SENSEEZD2013-02-28
1498091223835848K122078LOFRIC PRIMO, LOFRIC HYDRO-KITEZD2012-10-31
1498091654775071K121810OSSEOSPEED ANGLED ABUTMENT EVNHA2013-01-23
1498091773457571K113424LOFRIC SINGLE USE URINARY CATHETEREZD2012-04-17
1498091005453736K062444HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KITEZD2007-02-22
1498091147812230
1498091322673895
1498091745686225
1498091052727355
1498091084932040
1498091090435444
1498091104972075
1498091107855146
1498091136818635
1498091149542215
1498091150324452
1498091172763712
1498091184706287
1498091296317169
1498091379750310
1498091498293458
1498091511591906
1498091567763948
1498091609301238
1498091628960144
1498091631845077
1498091638143416
1498091654775071
1498091733281484
1498091747826263
1498091974968254
1498091986173087
1498092026574476

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EZD82026-04-24
KNT22019-11-22
NHA12013-01-23
KOD11990-08-06

PMN#