BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening

    Reg #: 3030907317 · FEI: 3030907317 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DaklaPack US Inc.
    Registration Number
    3030907317
    FEI Number
    3030907317
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 W Main St Ste 2
    City
    Wyckoff
    State
    NJ
    ZIP
    07481
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240045

    Owner / Operator

    Firm Name
    DaklaPack US Inc.
    Operator Number
    10093569
    Address
    500 West Main St, suite 2
    City
    Wyckoff
    State
    NJ
    Postal Code
    07481
    Country
    US
    Correspondent
    Andrew Muntean

    Products

    Device Name Product Code
    Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay SEP

    Proprietary Names

    Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening

    Establishment Types

    Repack or Relabel Medical Device