BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    THI TOTAL HEALTHCARE INNOVATION GMBH

    Reg #: 3017300722 · FEI: 3017300722 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    THI TOTAL HEALTHCARE INNOVATION GMBH
    Registration Number
    3017300722
    FEI Number
    3017300722
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gewerbestrasse 4
    City
    Feistritz im Rosental Karnten
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K222214

    Owner / Operator

    Firm Name
    THI Total Healthcare Innovation GmbH
    Operator Number
    10089072
    Address
    Gewerbestrasse 4
    City
    Feistritz im Rosental
    State
    Karnten
    Postal Code
    9181
    Country
    AT
    Correspondent
    Karl Hintermann

    US Agent

    Business Name
    Ivy Surgical Solutions, LLC
    Contact Name
    Vincent Bates
    Address
    202 Kings Hwy
    City
    Haddon Heights
    State
    NJ
    ZIP
    08035
    Country
    US
    Email
    [email protected]
    Phone
    858 8229433

    Products

    Device Name Product Code
    Hood, Surgical FXY
    Gown, Surgical FYA
    Helmet, Surgical FXZ

    Proprietary Names

    ViVi Helmet ViVi Helmet25XL ViVi Helmet25 ViVi Helmet25 HPL ViVi Helmet25XL HPL ViVi Helmet HPL

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device