BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGVARIS Inc. - Holland Facility

    Reg #: 3005550595 · FEI: 3005550595 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    17
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    SIGVARIS Inc. - Holland Facility
    Registration Number
    3005550595
    FEI Number
    3005550595
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13055 Riley St Ste 30
    City
    Holland
    State
    MI
    ZIP
    49424
    Country
    US

    Owner / Operator

    Firm Name
    Sigvaris Holding AG
    Operator Number
    8031005
    Address
    Sandgrube 29
    City
    Appenzell
    State
    Appenzell Innerrhoden
    Postal Code
    9050
    Country
    CH

    Products

    Device Name Product Code
    Protector, Skin Pressure FMP
    Binder, Medical, Therapeutic MDR
    Bandage, Elastic FQM
    Binder, Elastic KMO
    Stocking, Elastic ILG
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    Compression Garments; Chipsleeve, Chipsleeve Custom, Medaform Compression Garments (hand and foot); Compreboot Lite, Standard and Plus, Coolflex Standard Foot Compression Garments; Compreshape and Compreshape Capri Compression Garments (hand and foot); Medahand, Medaglove, Dorsal Pocket Glove Compression Garments (hand and foot); Compreflex Reduce Foot, Medaboot, Secure Glove and Gauntlet Compression Garments; Compreshorts, Compreshorts Capri, Custom and Capri Custom Compression Garments; Compreflex Reduce, Coolflex Standard, Neck & Mandible Pad Compression Garments; Comprevest, Custom only (Chipvest, Chipflow, Legassist, Armassist) Inelastic Wraps, Compreflex Standard, Transition, Complete and Contain Cotton Tubular WaveFoam Elasto-Soft Non-Woven Padding Biafoam Biagrip Compressive Biasoft Accessories, It Stays Adhesive

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198