BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Intraclude

    Reg #: 3007740583 · FEI: 3007740583 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMDS Operations B.V.
    Registration Number
    3007740583
    FEI Number
    3007740583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ceintuurbaan Noord 150
    City
    Roden Groningen
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K163693

    Owner / Operator

    Firm Name
    IMDS Operations B.V.
    Operator Number
    10029918
    Address
    Ceintuurbaan Noord 150
    City
    Roden
    State
    Drenthe
    Postal Code
    9301NZ
    Country
    NL
    Correspondent
    Edwin A Schulting

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Clamp, Vascular DXC

    Proprietary Names

    Intraclude

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)