BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    IVUS ILAC SANAYI VE TICARET AS

    Reg #: 3021632375 · FEI: 3021632375 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    50

    Registration Details

    Registration Name
    IVUS ILAC SANAYI VE TICARET AS
    Registration Number
    3021632375
    FEI Number
    3021632375
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Yesilkoy cad. No 25 Florya Bakirkoy
    City
    Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K172565
    PMA Number
    P900056

    Owner / Operator

    Firm Name
    IVUS ILAC SANAYI VE TICARET AS
    Operator Number
    10084070
    Address
    Yesilkoy cad. No 25 Florya Bakirkoy
    City
    Istanbul
    State
    TR-34
    Postal Code
    34153
    Country
    TR
    Correspondent
    Abuzer A Tandogan

    US Agent

    Business Name
    IVUS MEDICAL SUPPLY
    Contact Name
    Abuzer Tandogan
    Address
    6805 Rathbone PI
    City
    Gainesville
    State
    VA
    ZIP
    20155
    Country
    US
    Email
    [email protected]
    Phone
    202 9938601

    Products

    Device Name Product Code
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ
    Endoscopic Tissue Approximation Device OCW
    Staple, Implantable GDW
    Screw, Fixation, Bone HWC
    Catheter, Coronary, Atherectomy MCX
    Electrode, Electrocardiograph DRX
    Dislodger, Stone, Biliary LQR
    Forceps, Biopsy, Electric KGE
    Laparoscope, General & Plastic Surgery GCJ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Clip, Implantable FZP
    Tube, Tracheostomy (W/Wo Connector) BTO
    Bur, Ear, Nose And Throat EQJ
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Mesh, Surgical, Polymeric FTL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    System, Hemodialysis, Remote Accessories MON
    Neurological Stereotaxic Instrument HAW
    Orthopedic Stereotaxic Instrument OLO
    Stimulator, Nerve ETN
    Stapler, Surgical GAG
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Applier, Surgical, Clip GDO
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    Anti Fog Solution And Accessories, Endoscopy OCT
    Dilator, Esophageal KNQ
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Pneumoperitoneum Needle FHO
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Tube, Tracheal (W/Wo Connector) BTR
    Protector, Ostomy EXE
    Oximeter DQA
    Bur, Surgical, General & Plastic Surgery GFF
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Laryngoscope, Endoscope GCI
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Tube Tracheostomy And Tube Cuff JOH
    Stent, Ureteral FAD
    Hysteroscope (And Accessories) HIH
    Motor, Drill, Pneumatic HBB
    Mesh, Surgical, Deployer ORQ
    Needle, Suturing, Disposable GAB
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Instrument, Manual, Surgical, General Use MDM
    Bilirubin (Total And Unbound) In The Neonate Test System MQM

    Proprietary Names

    MD P BXT B CVT STR MSM VNT

    Establishment Types

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