BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vitrolife Inc.

    Reg #: 2031824 · FEI: 3002757762 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Vitrolife Inc.
    Registration Number
    2031824
    FEI Number
    3002757762
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4940 Carroll Canyon Rd Ste 100
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030117

    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

    Products

    Device Name Product Code
    Media, Reproductive MQL
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Radioimmunoassay, Luteinizing Hormone CEP
    Hemocytometer GHO

    Proprietary Names

    ENHANCE SPERM FREEZE Enhance Sperm Wash with & without Gentamicin PZD Pipette Handling Pipette Biopsy Pipette ICSI Pipette Hatching Pipette Holding Pipette ENHANCE-S PLUS HTF CELL ISOLATION MEDIUM OvuQuick One Step Ovulation Predictor Test MicroCell mHTF Enhance S-Plus Cell Isolation Medium

    Establishment Types

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