BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    VITROLIFE SWEDEN AB

    Reg #: 3003995932 · FEI: 3003995932 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    57
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    VITROLIFE SWEDEN AB
    Registration Number
    3003995932
    FEI Number
    3003995932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gustaf Werners Gata 2
    City
    Vastra Frolunda Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K243373

    Owner / Operator

    Firm Name
    VITROLIFE AB
    Operator Number
    9037178
    Address
    Gustaf Werners gata 2
    City
    Vastra Frolunda
    State
    Vastra Gotaland
    Postal Code
    SE-421 32
    Country
    SE
    Correspondent
    NINA - ARVIDSSON

    US Agent

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

    Products

    Device Name Product Code
    Catheter, Assisted Reproduction MQF
    Media, Reproductive MQL
    Labware, Assisted Reproduction MQK
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Needle, Assisted Reproduction MQE
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
    Tubing, Noninvasive GAZ
    Labware, Assisted Reproduction, Exempt PUD
    Transducer, Ultrasonic, Diagnostic ITX
    Media, Reproductive, Exempt QKI

    Proprietary Names

    EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm G-IVF PLUS Rapid-i Kit HSA-solution RapidVit Cleave/RapidWarm Cleave G-TL EmbryoGlue G-RINSE OVOIL RapidVit Blast, RapidWarm Blast SpermRinse PZD Pipette Handling Pipette Biopsy Pipette ICSI Pipette Hatching Pipette Holding Pipette Ultra RapidWarm Blast RapidWarm Oocyte RapidVit Oocyte FreezeKit Cleave, ThawKit Cleave Follicle Aspiration Set, Single Lumen Follicle Aspiration Set, Single Lumen Luer with Tubing Follicle Aspiration Set, Single Lumen, Luer Follicle Aspiration Set, Double Lumen Follicle Aspiration Set, Reduced Single Lumen Follicle Aspiration Set, Reduced Single Lumen, Luer Follicle Aspiration Set, Reduced Double Lumen Amniocentesis Needle Gx-IVF Gx-MOPS PLUS Gx-TL G-2 PLUS Vacuum Pump Tubing Culture Dish 40 mm Culture Dish 60 mm 5 Well Culture Dish Centrifuge Tube 50 mL Collection Dish 90 mm Centre Well Dish ICSI Dish Sample Tube 5 mL Centrifuge Tube 15 mL Micro-droplet Culture Dish Oocyte Collection Tube 14 mL Sperm Collection Container G-PGD ICSI Pasteur Pipette 3 mL Pasteur Pipette 1 mL SpermGrad G-MOPS/G-MOPS PLUS ASP G-1 PLUS Ultrasound Transducer Cover HYASE-10X OVOIL HEAVY

    Establishment Types

    Manufacture Medical Device