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    FDA Registration Active 🇹🇷 Türkiye

    SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI

    Reg #: 3014479313 · FEI: 3014479313 · Expires 2026
    View on FDA
    Products
    52
    Proprietary Names
    130
    Establishment Types
    2
    Classifications
    52

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    Registration Details

    Registration Name
    SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
    Registration Number
    3014479313
    FEI Number
    3014479313
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
    City
    Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K123109
    PMA Number
    P900056

    Owner / Operator

    Firm Name
    SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
    Operator Number
    10089530
    Address
    NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
    City
    Istanbul
    State
    TR-34
    Postal Code
    34758
    Country
    TR

    US Agent

    Business Name
    Liberty Management Group Ltd.
    Contact Name
    Manoj Zacharias
    Address
    75 Executive Drive,, Suite 114,
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

    Device Name Product Code
    Staple, Implantable GDW
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Clip, Implantable FZP
    Applier, Surgical, Clip GDO
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Stimulator, Nerve ETN
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Coronary, Atherectomy MCX
    Mesh, Surgical, Polymeric FTL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Motor, Drill, Pneumatic HBB
    Motor, Drill, Electric HBC
    Driver, Wire, And Bone Drill, Manual DZJ
    Hood, Surgical FXY
    Gown, Surgical FYA
    Tube, Tracheal (W/Wo Connector) BTR
    Instrument, Ultrasonic Surgical LFL
    Needle, Suturing, Disposable GAB
    Endoscopic Tissue Approximation Device OCW
    Electrode, Needle GXZ
    Electrode, Needle, Diagnostic Electromyograph IKT
    Needle, Hypodermic, Single Lumen FMI
    Neurological Stereotaxic Instrument HAW
    Tube Tracheostomy And Tube Cuff JOH
    Orthopedic Stereotaxic Instrument OLO
    Stapler, Surgical GAG
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
    Forceps, Obstetrical HDA
    Staple, Removable (Skin) GDT
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Arthroscope HRX
    Saw, Pneumatically Powered KFK
    Bur, Ear, Nose And Throat EQJ
    Suture, Absorbable, Natural GAL
    Pneumoperitoneum Needle FHO
    Tube, Tracheostomy (W/Wo Connector) BTO
    Instrument, Manual, Surgical, General Use MDM
    Laryngoscope, Endoscope GCI
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bur, Surgical, General & Plastic Surgery GFF
    Drill, Bone, Powered DZI
    Unit, Operative Dental EIA
    Motor, Surgical Instrument, Ac-Powered GEY
    Dislodger, Stone, Biliary LQR
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Anti Fog Solution And Accessories, Endoscopy OCT

    Proprietary Names

    Staple, Implantable ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) ENDO CLIP III 5MM CLIP APPLIER Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Electrosurgical, Cutting & Coagulation & Accessories Stimulator, Nerve MDT VersaOne Optical Trocar with Fixation Balloon Cannula VersaOne Universal Fixation Balloon Cannula CATHETER, CORONARY, ATHERECTOMY BS Mesh, Surgical, Polymeric MDT ORIGIN BLUNT TIP SURGICAL TROCAR Midas Rex LigaSure Exact Dissector, Nano-coated Premium Surgiclip; Endo Clip; AcuClip BURR HOODS AND TOGAS Shiley Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device Laparoscope, General & Plastic Surgery MEDTRONIC PROTACK Endoscopic Tissue Approximation Device ABSORBATACK FIXATION DEVICES AUTOSUTURE PROTACK; TACKER SYSTEM Open Sealer/Divider, Nano-coated Electrosurgical, Cutting & Coagulation & Accessories MDT LigaSure Impact Curved, Large Jaw Electrode Electrosurgical, Cutting & Coagulation & Accessories MEDTRONIC INSTRUMENT TRACKER Mesh, Surgical, Polymeric VersaOne Bladed Trocar, Ligasure Blunt Tip Sealer/Divider Endoscopic Tissue Approximation Device MDT LF1823; LigaSure™ Blunt Tip, Laparoscopic Sealer/Divider Nano-coated Ligasure Blunt Tip, Sealer/Divider, Nano-coated LigaSure™ Blunt Tip Open Sealer/Divider Nano-coated LF1837 and LF1844 VersaOne POLYHESIVE PATIENT RETURN ELECTRODE RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS shiley Sonicision Battery Charger, Sonicision Battery Insertion Guide Sonicision Reusable Generator, Sonicision Reusable Battery Pack Sonicision Curved Jaw Dissectors (multiple lengths) SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh) Parietex Composite Mesh (PCO and PCO-OS references) Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System) Progrip Laparoscopic Self-Fixating Mesh LPG1510AR LAPAROSCOPIC SELF-FIXATING MESH Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh) LPG1510AL LAPAROSCOPIC SELF-FIXATING MESH SILS STITCH ENDOSCOPIC SUTURING DEVICE Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece MDT Nano-coated LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944 Orthopedic Stereotaxic Instrument MEDTRONIC Stapler, Surgical Covidien Stapler ENDOBAG STRYKER STRI-SHIELD FLYTE TOGAS Prisma flex Motor, drill, pneumatic EEA Stapler Tri-Staple 2 Reinforced Reload AUTO SUTUREMENDOSCOPIC CLAMP SFS Stapler; Signet Appose Skin Staplers; ConcordeMultifire Premium skin stapler; McKesson Skin Staplers 35 REGULAR; McKesson Skin Staplers 35 WIDE ADT FLEX TRACH W TG CUFF VLOC9ABSORBABLE Laparoscope, General & Plastic Surgery COVIDIEN Spacemaker Pro Access and Dissector System FLYTE HOOD Probe VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR Easycap II AUTO SUTURE SURGICAL STAPLES Covidien Endo GIA Ultra Universal stapler Endo GIA Tm Reinforced Reload with Tn-Staple Tm Technology ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS DST SERIES(TM) TA(TM) STAPLERS Blade LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS LigaSure Atlas™ Tissue Fusion Open Instrument, LS1020 LigaSure Atlas™ Tissue Fusion Laparoscopic Instrument, LS1037 iBur hubs and cutting accessories LIGATING LOOP LigaSure Retractable L-Hook Laparoscopic Sealer/Divider Ligasure Small Jaw Tissue Fusion Instrument Mesh, Surgical, Polymeric MEDTRONIC V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Tube, Tracheal (W/Wo Connector) MDT PREPERITONEAL DISTENTION BALLOON SYSTEM Laparoscope, General & Plastic Surgery MDT Pneumoperitoneum Needle SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT Signia Instrument, Manual,Surgical,General Use PlasmaBlade X 3S, PlasmaBlade X 4 Peak Surgical Plasma Blade NERVE INTEGRITY MONITOR-2 (NIM-2 XL) Laryngoscope, endoscope MDT AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH STRYKER SAGITTAL SAW ATTACHMENT AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE STRYKER CROSSFIRE SYSTEM Shiley Adult LigaSure TMCurved, Snmall Jaw, Open Sealer / Divider (LFI 212) CLOSUREFAST RADIOFREQUENCY CATHETER ENT Blades & Burs STRYKER TOTAL PERFORMANCE (TPS) SYSTEM BLADE, SAW, GENERAL PLASTIC SUGERY, SURGICAL Precision Thin Bur, Ear, Nose And Throat MEDTRONIC Drills, Burrs, Trephines & Accessories (Simple, Powered) LigaSure™ XP Maryland Jaw Sealer/Divider Tube Tracheostomy And Tube Cuff Parietene Macroporous Mesh Covidien Optical Bladeless 12MM Standard Tricor VersaOne™ Bladeless Trocar Dislodger, Stone, Biliary SYMBOTEX(TM) COMPOSITE MESH SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP) DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)

    Establishment Types

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