BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Medica S.p.A.

    Reg #: 9615942 · FEI: 1000191953 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    Medica S.p.A.
    Registration Number
    9615942
    FEI Number
    1000191953
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    via degli Artigiani, 7
    City
    Medolla Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K000028

    Owner / Operator

    Firm Name
    Medica S.p.A.
    Operator Number
    9040626
    Address
    VIA degli Artigiani 7, --
    City
    MEDOLLA
    State
    Modena
    Postal Code
    41036
    Country
    IT
    Correspondent
    ROSSETTI - ANTONIO

    US Agent

    Business Name
    Medica USA Inc.
    Contact Name
    Greg Collins
    Address
    5610 Rowland Rd
    City
    Minnetonka
    State
    MN
    ZIP
    55343
    Country
    US
    Email
    [email protected]
    Phone
    952 6005763

    Products

    Device Name Product Code
    Device, Cystometric, Hydraulic FEN
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Pediatric Hemodialysis System QIR
    Subsystem, Water Purification FIP

    Proprietary Names

    Urology/Gastroenterology Disposable Catheters Renaflo II Hemofilter - HF 2000 Carpediem - preassembled disposable device Renaflo II Hemofilter - 400-700-1200 Purema H Hemoconcentrator Hemocor HP Hemoconcentrator - HP700 + TS Hemocor HP Hemoconcentrators - 400-1000-1400 + TS FiberFlo HPH Junior - High Performance Hemoconcentrator

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)