BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Dialysis Set, Catheter Set’

    Reg #: 3017059795 · FEI: 3017059795 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.
    Registration Number
    3017059795
    FEI Number
    3017059795
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Velimese Osb. Mah. 242 Sok. Subiomedikal Blok No:9/2 Ergene
    City
    Tekirdag
    Country
    TR

    Owner / Operator

    Firm Name
    Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A.S.
    Operator Number
    10074958
    Address
    Velimese Osb. Mah. 242 Sok. Subiomedikal Blok No:9/2 Ergene
    City
    Tekirdag
    State
    TR-59
    Postal Code
    59930
    Country
    TR

    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
    Tray, Start/Stop (Including Contents), Dialysis FKG

    Proprietary Names

    Dialysis Set, Catheter Set’ EASY HD Dialysis Set, EASY HD Fistula Kit, EASY HD Catheter Set, EASY HD Catheter Kit

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)