BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    DuraSheath Introducer Sheath System

    Reg #: 3038188187 · FEI: 3038188187 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O.
    Registration Number
    3038188187
    FEI Number
    3038188187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Nachodska 811
    City
    Hradec Kralove
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K181463

    Owner / Operator

    Firm Name
    Contract Medical International, spol. s r.o.
    Operator Number
    10093087
    Address
    Nachodska 811
    City
    Hradec Kralove
    State
    CZ-521
    Postal Code
    50301
    Country
    CZ
    Correspondent
    Klara Safrankova

    US Agent

    Business Name
    Heraeus Medevio
    Contact Name
    Timothy Desaulniers
    Address
    5030 Centerville Rd
    City
    Saint Paul
    State
    MN
    ZIP
    55127
    Country
    US
    Email
    [email protected]
    Phone
    612 3252003

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    DuraSheath Introducer Sheath System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)