BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    WATERS TECHNOLOGIES IRELAND, LTD.

    Reg #: 9616673 · FEI: 3003179344 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    7

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    Registration Details

    Registration Name
    WATERS TECHNOLOGIES IRELAND, LTD.
    Registration Number
    9616673
    FEI Number
    3003179344
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    WEXFORD BUSINESS PARK
    City
    DRINAGH Wexford
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K063868

    Owner / Operator

    Firm Name
    WATERS CORPORATION
    Operator Number
    1218959
    Address
    34 Maple Street
    City
    Milford
    State
    MA
    Postal Code
    01757
    Country
    US
    Correspondent
    Raajdeep Venkatesan

    US Agent

    Business Name
    Waters Corporation
    Contact Name
    Meghan Oliveira
    Address
    34 Maple St
    City
    Milford
    State
    MA
    ZIP
    01757
    Country
    US
    Email
    [email protected]
    Phone
    508 4822000

    Products

    Device Name Product Code
    Columns, Liquid Chromatography DPM
    Enzyme Immunoassay, Tracrolimus MLM
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Multi-Analyte Mixture JIX
    Mass Spectrometer, Clinical Use DOP

    Proprietary Names

    MASSTRAK C18 ACQUITY BEH ACQUITY HSS T3 ACQUITY BEH Phenyl MASS TRAK IMMUNOSUPPRESSANTS KIT MASS TRAK KIT CALIBRATOR MASS TRAK KIT QUALITY CONTROL MassTrak Immunosuppressant Quality Control Set MassTrak Steroid Serum QC Set 1 MassTrak Steroid Serum QC Set 3 MassTrak Steroid Serum QC Set 2 MassTrak Steroid Serum Cal Set 1 MassTrak Immunosuppressant Calibrator Set MassTrak Immunosuppressant Internal Standard Set MassTrak Endocrine Blank Calibrator MassTrak Steroid Serum Cal Set 3 MassTrak Steroid Internal Standard Mix MassTrak Steroid Serum Cal Set 2 MassTrak Steroid Optimization Mix Xevo TQ-S Micro Xevo TQ-XS Xevo TQ Xevo TQ-S ACQUITY TQD Xevo TQD Xevo TQ Absolute

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility