BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG

    Reg #: 3004006614 · FEI: 3004006614 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
    Registration Number
    3004006614
    FEI Number
    3004006614
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ODERSTRASSE 77
    City
    TELTOW Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K130785

    Owner / Operator

    Firm Name
    GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
    Operator Number
    9052369
    Address
    ODERSTRASSE 77, --
    City
    TELTOW
    State
    DE-NOTA
    Postal Code
    14513
    Country
    DE
    Correspondent
    Bert Schadow

    US Agent

    Business Name
    MDI CONSULTANTS, INC.
    Contact Name
    Alan P. Schwartz
    Address
    55 NORTHERN BLVD STE 200
    City
    GREAT NECK
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Holter Recorder, Product Code MWJ CardioMem CM 3000-12 BT CardioMem CM 3000-12 BT / SEER 12 CardioDay Holter Evaluation Software CardioDay V2.5 CardioDay v2.6 CardioDay v2.7

    Establishment Types

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