BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Cercare Perfusion (MRI)

    Reg #: 3019844085 · FEI: 3019844085 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CERCARE MEDICAL A/S
    Registration Number
    3019844085
    FEI Number
    3019844085
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Inge Lehmanns Gade 10
    City
    Aarhus Midtjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K202793

    Owner / Operator

    Firm Name
    Cercare Medical
    Operator Number
    10082009
    Address
    Inge Lehmanns Gade 10
    City
    Aarhus
    State
    Midtjylland
    Postal Code
    8000
    Country
    DK
    Correspondent
    Peter T Loekke

    US Agent

    Business Name
    JE Regulatory Consulting LLC
    Contact Name
    Jennifer Willner
    Address
    406 Wacouta St Unit 417
    City
    Saint Paul
    State
    MN
    ZIP
    55101
    Country
    US
    Email
    [email protected]
    Phone
    612 2408904

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Cercare Perfusion (MRI) Cercare Medical Neurosuite (CMN) with Capillary Function

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device