BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI

    Reg #: 3015453963 · FEI: 3015453963 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    56
    Establishment Types
    1
    Classifications
    59

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    Registration Details

    Registration Name
    CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI
    Registration Number
    3015453963
    FEI Number
    3015453963
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Cevizli Mah. Tansel Cad., No:12-18 Bulut Plaza D:32-33-34
    City
    Maltepe Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K052776
    PMA Number
    P010031

    Owner / Operator

    Firm Name
    Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti
    Operator Number
    10060492
    Address
    Cevizli Mah. Tansel Cad, No:12-18 Bulut Plaza D:32-33-34
    City
    Maltepe
    State
    Istanbul
    Postal Code
    34846
    Country
    TR

    US Agent

    Business Name
    ADVANCED INVENTORY INC
    Contact Name
    Jason Einhorn
    Address
    9645 Willow Ln
    City
    Mokena
    State
    IL
    ZIP
    60448
    Country
    US
    Email
    [email protected]
    Phone
    888 4162409

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Set, Administration, Intravascular FPA
    Catheter, Percutaneous DQY
    Wire, Guide, Catheter DQX
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Motor, Surgical Instrument, Pneumatic Powered GET
    Suture, Absorbable, Natural GAL
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Screw, Fixation, Bone HWC
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Programmer, Pacemaker KRG
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Introducer, Catheter DYB
    Oximeter, Ear DPZ
    Oximeter DQA
    Instrument, Manual, Surgical, General Use MDM
    Laparoscope, General & Plastic Surgery GCJ
    Mesh, Surgical, Polymeric FTL
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Catheter, Assisted Reproduction MQF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Bit, Drill HTW
    Neurological Stereotaxic Instrument HAW
    Catheter, Hemodialysis, Implanted, Coated NYU
    Catheter, Hemodialysis, Implanted MSD
    Staple, Implantable GDW
    Catheter, Urological KOD
    Pin, Fixation, Smooth HTY
    Catheter, Continuous Flush KRA
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Catheter, Intravascular, Diagnostic DQO
    Coronary Drug-Eluting Stent NIQ
    Accessories, Arthroscopic NBH
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Laparoscope, General & Plastic Surgery, Reprocessed NLM
    Catheter, Thrombus Retriever NRY
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Staple, Removable (Skin) GDT
    Forceps, Obstetrical HDA
    Clip, Implantable FZP
    Catheter, Irrigation GBX
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG
    Arthroscope HRX
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Bur, Ear, Nose And Throat EQJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Saw, Pneumatically Powered KFK
    Motor, Drill, Electric HBC
    Motor, Drill, Pneumatic HBB
    Catheter, Percutaneous, Neurovasculature QJP
    Permanent Defibrillator Electrodes NVY

    Proprietary Names

    WASHER, BOLT NUT Tubes, vials, systems, serum separators, blood collection CATHETER, PERCUTANEO WIRE, GUIDE, CATHETER Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED GAL LIT Catheter, angioplasty, peripheral, transluminal DQY CATHETER, PERCUTANEOUS Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) DYB Oximeter INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Laparoscope, general & plastic surgery CATHETER, PERCUTANEOUS Mesh, surgical, polymeric Fastener, fixation, nondegradable, soft tissue CATHETER, ASSISTED REPRODUCTION ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED BIT, DRILL Endosurgical FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MSD STAPLE, IMPLANTABLE CATHETER, UROLOGICAL Electrosurgical, cutting & coagulation & accessories Fixation, pin Catheter, continuous flush FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE CATHETER, INTRAVASCULAR, DIAGNOSTIC Coronary drug-eluting stent Accessories, arthroscopic SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAT - Suture, nonabsorbable, synthetic, polyethylene Laparoscope, General & Plastic Surgery, Reprocessed Catheter, Thrombus Retriever Catheters, transluminal coronary angioplasty, percutaneous STAPLE, REMOVABLE (SKIN) Forceps, obstetrical CLIP, IMPLANTABLE CATHETER, IRRIGATION DQX CATHETER, THROMBUS RETRIEVER Wire, guide, catheter KRD,HCG INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT MOTOR DRILL, PNEUMATIC Catheter, intravascular, diagnostic Introducer, catheter Suture, nonabsorbable, synthetic, polyethylene Screw, fixation, bone Permanent defibrillator electrodes Guide wire Catheter, Percutaneous GEI

    Establishment Types

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