BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    pfm medical mepro gmbh

    Reg #: 3005704822 · FEI: 3005704822 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    9
    Establishment Types
    4
    Classifications
    12

    Registration Details

    Registration Name
    pfm medical mepro gmbh
    Registration Number
    3005704822
    FEI Number
    3005704822
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Am Soterberg 4
    City
    Nonnweiler-Otzenhausen Saarland
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K011783
    PMA Number
    P120009

    Owner / Operator

    Firm Name
    PFM MEDICAL GMBH
    Operator Number
    9035772
    Address
    1916 Palomar Oaks Way
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Jessica Jho

    Products

    Device Name Product Code
    Catheter Introducer Kit OFC
    Apparatus, Melting Point, Paraffin IDT
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Catheter, Embolectomy DXE
    Bottle, Collection, Vacuum KDQ
    Transcatheter Septal Occluder (Ventricular) OZH
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Device, Percutaneous Retrieval MMX
    Occluder, Patent Ductus, Arteriosus MAE
    Transcatheter Septal Occluder MLV
    Microtome, Sliding KFL
    Transcatheter Septal Occluder (Atrial) OZG

    Proprietary Names

    Micro Introducer CTS 500 Cassette Trimming System Port MULTISNARE primePICC Nit-Occlud PDA Nit-Occlud PFO Nit-Occlud TISSUE PROCESSING EQUIPMENT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device