BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VITROMED GmbH

    Reg #: 3016126174 · FEI: 3016126174 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    VITROMED GmbH
    Registration Number
    3016126174
    FEI Number
    3016126174
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Raiffeisen Str 15a
    City
    Langenfeld (Rheinland) North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K241833

    Owner / Operator

    Firm Name
    VITROMED GmbH
    Operator Number
    10062050
    Address
    Goschwitzer Str. 22
    City
    Jena
    State
    DE-NOTA
    Postal Code
    07745
    Country
    DE

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    305 5999373

    Products

    Device Name Product Code
    Media, Reproductive MQL
    Microtools, Assisted Reproduction (Pipettes) MQH
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Media, Reproductive, Exempt QKI

    Proprietary Names

    V-GRAD V-ONESTEP V-PVP V-DENUPET V-VITWARM (V-TS-KIT: V-THAWING SOLUTION; V-TS-4) V-VITFREEZE (V-FS-KIT: V-EQUILIBRATION SOLUTION; V-ES-2) V-VITWARM (V-TS-KIT: V-WASHING SOLUTION; V-WS-4) V-VITFREEZE (V-FS-KIT: V-VITRIFICATION SOLUTION; V-VS-2) V-VITWARM (V-TS-KIT: V-DILUENT SOLUTION; V-DS-4) V-HEPES PLUS V-HYADASE V-ICSIPET V-SPERM WASH V-OIL

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)