BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    OMNIA SRL

    Reg #: 3004361903 · FEI: 3004361903 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    28
    Establishment Types
    4
    Classifications
    24

    Registration Details

    Registration Name
    OMNIA SRL
    Registration Number
    3004361903
    FEI Number
    3004361903
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA F.DELNEVO 190
    City
    FIDENZA Parma
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K911334

    Owner / Operator

    Firm Name
    Omnia SRL
    Operator Number
    9059817
    Address
    1666 E Touhy Ave
    City
    Des Plaines
    State
    IL
    Postal Code
    60018
    Country
    US

    US Agent

    Business Name
    Hu-Friedy Mfg Co LLC
    Contact Name
    Stephanie Wasielewski
    Address
    1666 E Touhy Ave
    City
    Des Plaines
    State
    IL
    ZIP
    60018
    Country
    US
    Email
    [email protected]
    Phone
    847 2574500

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Mask, Surgical FXX
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Holder, Film, X-Ray EGZ
    Gauze / Sponge,Nonresorbable For External Use NAB
    Instruments, Dental Hand DZN
    Drape, Surgical, Antimicrobial KKX
    General Surgery Tray LRO
    Gown, Surgical FYA
    Accessory, Surgical Apparel LYU
    Film, Camera, Surgical FXT
    Unit, Operative Dental, Accessories NRD
    Table And Attachments, Operating-Room BWN
    Cap, Surgical FYF
    Chair, Dental, Without Operative Unit NRU
    Mouthpiece, Saliva Ejector DYN
    Unit, Oral Irrigation EFS
    Accessories, Retractor, Dental EIF
    Catheter, Irrigation GBX
    Operating Room Accessories Table Tray FWZ
    Suit, Surgical FXO
    Punch, Biopsy, Surgical EME
    Non-Surgical Gown OEA
    Drape, Adhesive, Aerosol KGT

    Proprietary Names

    Omnia Kidney Tray Omnia procedure mask Suture Omnia in PTFE RAY BARRIER LIGHT BARRIER OMNITEX C SENSOTEX OMNITEX U PTFE sutures Hu-Friedy STERILE AND NON STERILE GAUZES MAXIL SURGICAL PROCEDURE PACKS Omnia surgical accessories STERILE PROTECTION FILM Omnia Surgical line OMNICAPS Omnitex sheath SplitAir Omnia Surgical Drape IRRIGATION LINE maxil tray for instruments Tubing set disposable, Disposable tube Omnia accessories NON STERILE OPERATOR PROTECTION TISSUE PUNCH Omnia Isolation Gowns Omnia Medical Adhesives

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)