BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Ostoform FLOWASSIST Closed Pouch

    Reg #: 3015332213 · FEI: 3015332213 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OSTOFORM LTD
    Registration Number
    3015332213
    FEI Number
    3015332213
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace
    City
    Mullingar Westmeath
    Country
    IE

    Owner / Operator

    Firm Name
    Ostoform Ltd
    Operator Number
    10060178
    Address
    Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace
    City
    Mullingar
    State
    Westmeath
    Postal Code
    N91 H635
    Country
    IE

    US Agent

    Business Name
    Ostoform Inc
    Contact Name
    Kevin Kelleher
    Address
    200 E Main St Ste 910
    City
    Fort Wayne
    State
    IN
    ZIP
    46802
    Country
    US
    Email
    [email protected]
    Phone
    260 9016338

    Products

    Device Name Product Code
    Collector, Ostomy EXB

    Proprietary Names

    Ostoform FLOWASSIST Closed Pouch Ostoform FLOWASSIST Drainable Pouch Ostoform Belt Ostoform FLOWASSIST Urostomy Pouch

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility