BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    FARMACO QUIMICA NACIONAL, S.A.

    Reg #: 3003755939 · FEI: 3003755939 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    34

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    Registration Details

    Registration Name
    FARMACO QUIMICA NACIONAL, S.A.
    Registration Number
    3003755939
    FEI Number
    3003755939
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle Jose Aybar Castellanos, No. 155
    City
    La Esperilla Santo Domingo
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K083435

    Owner / Operator

    Firm Name
    Farmaco Quimica Nacional, S.A.
    Operator Number
    10083312
    Address
    Calle Jose Aybar Castellanos, No. 155
    City
    La Esperilla
    State
    Santo Domingo
    Postal Code
    10107
    Country
    DO

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Instrument, Special Lens, For Endoscope FEI
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Dressing, Wound, Drug FRO
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Instrument, Manual, Surgical, General Use MDM
    Cerclage, Fixation JDQ
    Platelet And Plasma Separator For Bone Graft Handling ORG
    System, Suction, Lipoplasty For Removal QPB
    Arthroscope HRX
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Apparatus, Traction, Non-Powered HST
    Accessories, Arthroscopic NBH
    Medical Device Data System OUG
    Camera, Surgical And Accessories KQM
    Bur, Surgical, General & Plastic Surgery GFF
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Insufflator, Laparoscopic HIF
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Bit, Drill HTW
    Reamer HTO
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Orthopedic Manual Surgical Instrument LXH
    Pin, Fixation, Smooth HTY
    Light, Surgical, Fiberoptic FST
    Syringe, Piston FMF
    Staple, Fixation, Bone JDR
    Staple Driver HXJ

    Proprietary Names

    INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Apparatus, traction, non-powered Accessories, arthroscopic Medical Device Data System CAMERA, SURGICAL AND ACCESSORIES BUR, SURGICAL, GENERAL & PLASTIC SURGERY centrifuges (micro, ultra, refrigerated) for clinical use INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Bit, Drill Reamer MINI TIGHTROPE Orthopedic manual surgical instrument

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device