BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Terumo BCT Europe N.V.

    Reg #: 3010425916 · FEI: 3010425916 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Terumo BCT Europe N.V.
    Registration Number
    3010425916
    FEI Number
    3010425916
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Medical Electronics, Romeinsestraat 8
    City
    Leuven Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K991160

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    US Agent

    Business Name
    Terumo BCT, Inc.
    Contact Name
    Corrine Lucas
    Address
    11158 W. COLLINS AVENUE
    City
    Lakewood
    State
    CO
    ZIP
    80215
    Country
    US
    Email
    [email protected]
    Phone
    720 6106034

    Products

    Device Name Product Code
    Device, Heat-Sealing KSD
    Warmer, Blood, Non-Electromagnetic Radiation BSB

    Proprietary Names

    T-SEAL II Astotubes Astoline Astotherm Plus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device