BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Indiko, product no. 98630000

    Reg #: 9610942 · FEI: 3007262384 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    THERMO FISHER SCIENTIFIC OY
    Registration Number
    9610942
    FEI Number
    3007262384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 RATASTIE
    City
    VANTAA Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K110035

    Owner / Operator

    Firm Name
    THERMO FISHER SCIENTIFIC INC.
    Operator Number
    2182773
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    US Agent

    Business Name
    Director, Quality and Regulatory Compliance
    Contact Name
    Jason Erickson
    Address
    46500 Kato Road
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US
    Email
    [email protected]
    Phone
    510 3810931

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hexokinase, Glucose CFR

    Proprietary Names

    Indiko, product no. 98630000 Indiko Plus, product no. 98640000

    Establishment Types

    Manufacture Medical Device