BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    THERMO FISHER SCIENTIFIC OY

    Reg #: 9610942 · FEI: 3007262384 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    49
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    THERMO FISHER SCIENTIFIC OY
    Registration Number
    9610942
    FEI Number
    3007262384
    Status
    Active
    Expiry Year
    2026
    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
    Senior Manager, Regulatory Affairs
    Contact Name
    Jonathan Abed
    Address
    168 3rd Ave
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    541 5884918

    Products

    Device Name Product Code
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Cuvette, Thermostated JRI
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hexokinase, Glucose CFR
    Detergent JCB

    Proprietary Names

    U-TURN, Mek INTERNAL U-TURN PARALLEL BYPASS OLYMPUS AU680 RECAPPER 110 VAC 60 HZ Parallel Bypass TOSOH G8 TCA 800 INTERFACE FOR COBAS 8000 ALIQUOTER AND LABELLER LOADER, product no. 952312 Z-TURN, LEFT EXIT INTERFACE ImmunoCap 1000 CONVEYOR 1200 MM ENTRY Procleix Reagent Preparation Incubator RPI 250 (120V & 220-240V) CONVEYOR 2100 MM PARALLEL BYPASS LIAISON XL SYSMEX HST Interface DECAPPER FLEX INTERFACE ARCHITECT C8000 Z-TURN, RIGHT STAGO STA-R INTERFACE CONVEYOR 1800 MM PERPENDICULAR BYPASS, TCA for COLD STORAGE RACK LOADER, product no. 952292 T-TURN PARALLEL BYPASS TOSOH CENTRIFUGE MODULE PARALLEL BYPASS BECKMAN Unicel Dxl 800 ES Flex PARALLEL BYPASS FOR ACL Top STORAGE, product no. 952311 PARALLEL BYPASS VITROS 5.1 FS BUFFER CONVEYOR 900 MM CONVEYOR 2400 MM CONVEYOR 600 MM Propleix Reagent Preparation Incubator RPI (120V & 220-240V) CONVEYOR 1500 MM L-TURN LAS PC Win10 including SW TCA CONTROLLER PC Including SW Win10 INTERFACE ARCHITECT i2000SR PERPENDICULAR BYPASS VITROS 5.1 FS BULK INTERFACE MODULE CENTRIFUGE FLEX MODULE Tencell cuvette Optilite Indiko, product no. 98630000 Indiko Plus, product no. 98640000 Washing Solution 4.5%, Product No. IK703, IK704, 984030, 980929

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)