BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Scleral Buckling Products

    Reg #: 9611516 · FEI: 3002806863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    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
    K023481

    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
    Implant, Orbital, Extra-Ocular HQX

    Proprietary Names

    Scleral Buckling Products

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device