BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ECM EUROPE BV

    Reg #: 3003018304 · FEI: 3003018304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ECM EUROPE BV
    Registration Number
    3003018304
    FEI Number
    3003018304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oost-Om 54
    City
    Gemert Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    BK050058

    Owner / Operator

    Firm Name
    ECM Europe BV
    Operator Number
    10084824
    Address
    Oost-Om 54
    City
    Gemert
    State
    Noord-Brabant
    Postal Code
    5422VZ
    Country
    NL

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Device, Warming. Blood And Plasma KZL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)