FDA.reportPublic FDA data

TST GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30160961433016096143TST GmbH1N2026-01-01Marie-Curie-Str. 1a Gernsheim Hesse DE 64579

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2347221678469843K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
2347222042201781K2435055008X Hemodialysis SystemKDI2025-05-30
2347221787097501K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO2023-12-01
2347222042101999K232953AquaBplus; AquaB LITEFIP2024-06-13
2347221180042780K2315345008X Hemodialysis SystemKDI2024-02-02
2347221865982715K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000KDI2023-05-11
2347221378576885K213507AquaAFIP2022-07-27
2347221153894269K191407Novalung SystemQJZ2020-02-21
2347221020650884K162716bibagKPO2017-05-18
2347221087753780K143617AquaC UNO HFIP2015-10-19
2347222038531414K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
2347221667226382K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FIP52024-06-13
KDI32025-05-30
KPO22023-12-01
QJZ12020-02-21
KDJ12008-12-29