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    FDA Registration Active 🇹🇷 Türkiye

    MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI

    Reg #: 3014279513 · FEI: 3014279513 · Expires 2026
    View on FDA
    Products
    71
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    71

    Registration Details

    Registration Name
    MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI
    Registration Number
    3014279513
    FEI Number
    3014279513
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Ilkbahar Mahallesi, 620 Sokak No 5
    City
    Cankaya Ankara
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K220540
    PMA Number
    P050038

    Owner / Operator

    Firm Name
    MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI
    Operator Number
    10057109
    Address
    Ilkbahar Mahallesi, 620 Sokak No 5
    City
    Cankaya
    State
    Ankara
    Postal Code
    06550
    Country
    TR
    Correspondent
    Mustafa Akin

    US Agent

    Business Name
    REGGAE REGISTERED AGENTS INC.
    Contact Name
    Yasemen Celik
    Address
    1401 Pennsylvania Ave Ste 105
    City
    Wilmington
    State
    DE
    ZIP
    19806
    Country
    US
    Email
    [email protected]
    Phone
    302 8428687

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL
    Screw, Fixation, Bone HWC
    Intrauterine Tamponade Balloon OQY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Absorbable, Synthetic GAN
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Staple, Implantable GDW
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Cannula, Manipulator/Injector, Uterine LKF
    Laparoscope, General & Plastic Surgery GCJ
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Laparoscope, Gynecologic (And Accessories) HET
    Endoscopic Tissue Approximation Device OCW
    Electrocautery, Gynecologic (And Accessories) HGI
    Instrument, Ultrasonic Surgical LFL
    Radioimmunoassay, Free Thyroxine CEC
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Colonoscope And Accessories, Flexible/Rigid FDF
    Clip, Implantable FZP
    Calibrator, Secondary JIT
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Stapler, Surgical GAG
    Stimulator, Nerve ETN
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Wire, Guide, Catheter DQX
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Insufflator, Hysteroscopic HIG
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Subsystem, Water Purification FIP
    Led Light Source NTN
    Light Source, Fiberoptic, Routine FCW
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Obturator, For Endoscope FEC
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Kit, Nephroscope FGA
    Pouch, Colostomy EZQ
    Catheters, Salpingography MOV
    Motor, Drill, Pneumatic HBB
    Camera, Still, Surgical FTT
    Applier, Surgical, Clip GDO
    Apparatus, Pneumoperitoneum, Automatic FDP
    Catheter, Intracardiac Mapping, High-Density Array MTD
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Insufflator, Laparoscopic HIF
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Biopsy Needle FCG
    Instrument, Biopsy KNW
    Hysteroscope (And Accessories) HIH
    Urethroscope FGC
    Telescope, Rigid, Endoscopic FBP
    Tube, Tracheal (W/Wo Connector) BTR
    Laryngoscope, Endoscope GCI
    Mammary Sizer MRD
    Instrument, Manual, Surgical, General Use MDM
    Clip, Hemostatic MCH
    Applier, Hemostatic Clip HBT
    Agent, Absorbable Hemostatic, Non-Collagen Based LMG
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Cystourethroscope FBO
    Forceps, Obstetrical HDA
    Nail, Fixation, Bone JDS
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Tissue Expander And Accessories LCJ
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Establishment Types

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