BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    THD SPA

    Reg #: 3006680097 · FEI: 3006680097 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    116
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    THD SPA
    Registration Number
    3006680097
    FEI Number
    3006680097
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via per Carpi, 15/B
    City
    Correggio Reggio Emilia
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K081429

    Owner / Operator

    Firm Name
    THD SpA
    Operator Number
    10025818
    Address
    Via per Carpi, 15/B
    City
    Correggio
    State
    Reggio Emilia
    Postal Code
    42015
    Country
    IT
    Correspondent
    Filippo Bastia

    US Agent

    Business Name
    THD America Inc.
    Contact Name
    Filippo bastia
    Address
    1731 SE Oralabor Road
    City
    Ankeny
    State
    IA
    ZIP
    50021
    Country
    US
    Email
    [email protected]
    Phone
    866 3749442

    Products

    Device Name Product Code
    Monitor, Ultrasonic, Nonfetal JAF
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Monitor, Esophageal Motility, Anorectal Motility, And Tube KLA
    Anoscope And Accessories FER
    Endoscope, Ac-Powered And Accessories GCP
    Proctoscope GCF
    Forceps, Biopsy, Non-Electric FCL
    Medical Device Data System OUG
    Ligator, Hemorrhoidal FHN
    Bulb, Inflation, For Endoscope FCY
    Camera, Television, Endoscopic, Without Audio FWF
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Camera, Television, Endoscopic, With Audio FWG
    Powered Laser Surgical Instrument GEX
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    THD Evolution USB Probe, ER12MHZ THD EAUS PROBE 12 MHZ THD DIGITAL MOBILE ECOGRAPHY THD DIGITAL MOBILE ADVANCED THD PRESSPROBE (ENV 200) THD PRESSPROBE (BOX) THD PRESSPROBE (ENV 100) THD PRESSKIT (TR ENV 100) THD PRESSPROBE (BOX 10) THD PRESSKIT (TR ENV 50) THD PRESSPROBE (ENV 50) THD PRESSKIT (TR BOX 10) THD PRESSPROBE (ENV) THD PRESSKIT (TR ENV) THD PRESSKIT (FL ENV 100) THD PRESSKIT (FL BOX) THD ANOPRESS THD PRESSKIT (FL BOX 10) THD PRESSKIT (TR BOX) THD PRESSKIT (TR ENV 200) THD PRESSKIT (FL ENV 200) THD PRESSKIT (FL ENV 50) THD PRESSKIT (FL ENV) THD MINI-RECTO (NS) THD MAXI-RECTO (NS) THD N-ANO MAXI (TR) THD N-ANO MAXI (BE) THD N-ANO (TR) THD N-ANO DIGITAL MAXI (TR) THD N-ANO (BE) THD N-ANO DIGITAL MAXI (BE) THD N-ANO DIGITAL (TR) THD N-ANO DIGITAL (BE) THD S-ANO (BE/NS) THD M-ANO (BE/NS) THD L-PROCTO (TR/NS) THD L-PROCTO (BE/NS) THD L-ANO (TR/NS) THD S-ANO (BE/ST) THD S-ANO (TR/NS) THD M-ANO (TR/ST) THD M-PROCTO (BE/ST) THD SURGY MINI (ST) THD M-ANO (BE/ST) THD M-PROCTO (TR/NS) THD M-ANO (TR/NS) THD L-ANO (BE/NS) THD M-PROCTO (BE/NS) THD S-ANO (TR/ST) THD L-ANO (BE/ST) THD L-ANO (TR/ST) THD SURGY MAXI (ST) THD BIOPSY (J) THD BIOPSY (GI - XL) THD BIOPSY (GI) Daisy, Maestro THD Bandy THD REVOLUTION THD REVOLUTION ACCESSORIES PACK US THD OPTI-FIBER (REVO/BT) THD REVOLUTION US THD DOPPLER PROBE (1s/ST) THD OPTI-FIBER (EVO/BT) THD EVOLUTION ACCESSORIES PACK US THD ANOLIFT US THD OPTI-FIBER (EVO/BT-880002) THD OPTI-FIBER (EVO/CA) THD SLIDE ONE USA THD EVOLUTION WITH ACCESSORIES THD SLIDE THD EVOLUTION US THD RE-NEEDHOLD (NS) THD LIGHT-SCOPE RECTO MAXI (LED INS/NS) THD LIGHT-SCOPE ANO (BE/NS) THD LIGHT-SCOPE MAXI-RECTO (INS/NS) THD LIGHT-SCOPE MINI-RECTO (NS) THD LIGHT-SCOPE ANO (TR/NS) THD LIGHT-SCOPE ANO (LED BE/NS) THD LIGHT-SCOPE RECTO MINI (LED NS) THD LIGHT-SCOPE MINI-RECTO (INS/NS) THD LIGHT-SCOPE SURGY MINI (NS) THD LIGHT-SCOPE MAXI-RECTO (NS) THD LIGHT-SCOPE RECTO MINI (LED INS/NS) THD LIGHT-SCOPE ANO (LED TR/NS) THD LIGHT-SCOPE RECTO MAXI (LED NS) Inflation Bulb THD LIGHT-SCOPE MAXI-RECTO (LED INS/ST) THD LIGHT-SCOPE MAXI-RECTO (ST) THD LIGHT-SCOPE SURGY MAXI (LED ST) THD LIGHT-SCOPE MAXI-RECTO (LED ST) THD LIGHT-SCOPE ANO (BE/ST) THD LIGHT-SCOPE MINI-RECTO (LED INS/ST) THD LIGHT-SCOPE ANO (TR/ST) THD LIGHT-SCOPE ANO (LED BE/ST) THD LIGHT-SCOPE SURGY MINI (LED ST) THD LIGHT-SCOPE MINI-RECTO (LED ST) THD LIGHT-SCOPE MAXI-RECTO (INS/ST) THD LIGHT-SCOPE MINI-RECTO (INS/ST) THD LIGHT-SCOPE ANO (LED TR/ST) THD LIGHT-SCOPE MINI-RECTO (ST) THD LIGHT-SCOPE PROCTO HRA THD 4K CAM THD DIGITAL MINICAM TRUGLYDE ABSORBABLE SURGICAL SUTURE U.S.P. (Braided and Coated Polyglycolic Acid) THD PROCTOMOBILE THD DIGITAL MOBILE LIGHT THD PROCTOSTATION THD PROCTO SOFTWARE THD DIGITAL MOBILE MANOMETRY THD DIGITAL MOBILE THD HRSTATION THD SENSYPROBE ACCESSORY THD SENSYPROBE MediCam Plus HRA Camera 2

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device