BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Vitrolife A/S

    Reg #: 3009107689 · FEI: 3009107689 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Vitrolife A/S
    Registration Number
    3009107689
    FEI Number
    3009107689
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Jens Juuls Vej 16
    City
    Viby J Midtjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K182798

    Owner / Operator

    Firm Name
    Vitrolife A/S
    Operator Number
    10040532
    Address
    Jens Juuls Vej 16
    City
    Viby J
    State
    DK-NOTA
    Postal Code
    8260
    Country
    DK
    Correspondent
    Belinda Dueholm

    US Agent

    Business Name
    Vitrolife Inc.
    Contact Name
    Erin Schardt
    Address
    3601 S Inca St
    City
    Englewood
    State
    CO
    ZIP
    80110
    Country
    US
    Email
    [email protected]
    Phone
    727 4247916

    Products

    Device Name Product Code
    Embryo Image Assessment System, Assisted Reproduction PBH
    Labware, Assisted Reproduction MQK
    Accessory, Assisted Reproduction MQG
    Microscope And Microscope Accessories, Reproduction, Assisted MTX
    System, Assisted Reproduction Laser MRX

    Proprietary Names

    KIDScore D3 EmbryoSlide+ ic8 dish EmbryoScope Version D and EmbryoSlide EmbryoScope time-lapse incubator EmbryoViewer EmbryoSlide+ culture dish ES Server software EmbryoViewer software EmbryoScope+ incubator EmbryoSlide culture dish EmbryoScope Version D EmbryoScope Version D and EmbryoViewer software LaserShot M NaviLase

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)