BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    EVA, combined machine including Laser (SMA connector)

    Reg #: 9611516 · FEI: 3002806863 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    Registration Number
    9611516
    FEI Number
    3002806863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SCHEIJDELVEWEG 2
    City
    ZUIDLAND Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K142877

    Owner / Operator

    Firm Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.
    Operator Number
    8030460
    Address
    SCHEIJDELVEWEG 2, --
    City
    ZUIDLAND
    State
    Zuid-Holland
    Postal Code
    3214 VN
    Country
    NL
    Correspondent
    Michel - van der Schans

    US Agent

    Business Name
    Dutch Ophthalmic USA
    Contact Name
    Deborah Thibodeaux
    Address
    10 Continental Drive, Bldg 1
    City
    Exeter
    State
    NH
    ZIP
    03833
    Country
    US
    Email
    [email protected]
    Phone
    603 7786929 ext. 170

    Products

    Device Name Product Code
    Unit, Phacofragmentation HQC
    Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE
    Laser, Ophthalmic HQF

    Proprietary Names

    EVA, combined machine including Laser (SMA connector) EVA, anterior machine EVA, combined machine EVA, combined machine including Laser (DORC connector)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device