BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    5-DIAGNOSTICS

    Reg #: 3012289015 · FEI: 3012289015 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    4

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    Registration Details

    Registration Name
    5-DIAGNOSTICS
    Registration Number
    3012289015
    FEI Number
    3012289015
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Heuberg 7
    City
    CH-4051 Basel Basel-Landschaft
    Country
    CH

    Owner / Operator

    Firm Name
    5-Diagnostics
    Operator Number
    10094384
    Address
    Heuberg 7
    City
    CH-4051 Basel
    State
    Basel-Landschaft
    Postal Code
    4051
    Country
    CH

    US Agent

    Business Name
    Aniara Diagnostica, Inc.
    Contact Name
    Michele Washing
    Address
    7768 Service Center Dr
    City
    West Chester
    State
    OH
    ZIP
    45069
    Country
    US
    Email
    [email protected]
    Phone
    513 3422075

    Products

    Device Name Product Code
    General Purpose Reagent PPM
    Plasma, Coagulation Control GGN
    Calibrator, Multi-Analyte Mixture JIX
    Calibrator, Secondary JIT

    Proprietary Names

    DOAC-Remove 5-PLASMA Bivalirudin Control 5-PLASMA Bivalirudin Calibrator 5-Plasma Bivalirudin AMR Verification Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device