BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    TST GmbH

    Reg #: 3016096143 · FEI: 3016096143 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    8

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    Registration Details

    Registration Name
    TST GmbH
    Registration Number
    3016096143
    FEI Number
    3016096143
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Marie-Curie-Str. 1a
    City
    Gernsheim Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K220721

    Owner / Operator

    Firm Name
    FRESENIUS MEDICAL CARE
    Operator Number
    8010838
    Address
    ELSE KROENER-STRASSE 1, --
    City
    BAD HOMBURG
    State
    Hesse
    Postal Code
    D-61352
    Country
    DE

    US Agent

    Business Name
    VP Regulatory Affairs NA
    Contact Name
    Denise Oppermann
    Address
    920 Winter St
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 9969103

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Subsystem, Water Purification FIP
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Accessories, Blood Circuit, Hemodialysis KOC
    Disinfectant, Dialysate Delivery System NII
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ

    Proprietary Names

    FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 AquaC UNO H pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406 AquaA Fresenius Sterile Stay Safe Cap 5008X Hemodialysis System bibag AquaBplus AquaB LITE AquaBplus & AquaBplus B2 & AquaBplus HF AquaBplus & AquaBplus B2 AquaBplus & AquaBplus HF Novalung DIASAFEplusUS

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device