BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI

    Reg #: 3011989923 · FEI: 3011989923 · Expires 2026
    View on FDA
    Products
    87
    Proprietary Names
    93
    Establishment Types
    2
    Classifications
    87

    Registration Details

    Registration Name
    DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI
    Registration Number
    3011989923
    FEI Number
    3011989923
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler
    City
    Istanbul
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K123425
    PMA Number
    P030049

    Owner / Operator

    Firm Name
    Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
    Operator Number
    10060275
    Address
    Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler
    City
    Istanbul
    State
    TR-34
    Postal Code
    34235
    Country
    TR

    US Agent

    Business Name
    FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park West Ste 4D
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Acid, Folic, Radioimmunoassay CGN
    Radioimmunoassay, Cortisol CGR
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Laparoscope, General & Plastic Surgery GCJ
    System, Test, Thyroid Autoantibody JZO
    Calibrator, Secondary JIT
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    Calibrator, Primary JIS
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Accessories, Arthroscopic NBH
    Staple, Implantable GDW
    Clip, Implantable FZP
    Radioassay, Vitamin B12 CDD
    Radioimmunoassay, Estradiol CHP
    Forceps, Obstetrical HDA
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Test, Natriuretic Peptide NBC
    Radioimmunoassay, Luteinizing Hormone CEP
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Screw, Fixation, Bone HWC
    Mesh, Surgical, Polymeric FTL
    Stapler, Surgical GAG
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
    Radioimmunoassay, Progesterone JLS
    Azo Dye, Calcium CJY
    Albumin, Antigen, Antiserum, Control DCF
    Lenses, Soft Contact, Daily Wear LPL
    Lens, Contact, (Disposable) MVN
    Instrument, Ultrasonic Surgical LFL
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM
    Washer, Bolt Nut HTN
    Diazo Colorimetry, Bilirubin CIG
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO
    Pneumoperitoneum Needle FHO
    Radioimmunoassay, Parathyroid Hormone CEW
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Arthroscope HRX
    Radioimmunoassay, Free Thyroxine CEC
    General Purpose Reagent PPM
    Radioimmunoassay, Total Triiodothyronine CDP
    Biuret (Colorimetric), Total Protein CEK
    Hexokinase, Glucose CFR
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Photometric Method, Iron (Non-Heme) JIY
    Photometric Method, Magnesium JGJ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Phenobarbital DLZ
    Bromcresol Purple Dye-Binding, Albumin CJW
    Electrode, Ion Specific, Calcium JFP
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Glucose Oxidase, Glucose CGA
    Conductivity Rate, Urea Nitrogen LFP
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Ph Rate Measurement, Carbon-Dioxide JFL
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    System, Test, Vitamin D MRG
    Bromcresol Green Dye-Binding, Albumin CIX
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Radioimmunoassay, Immunoreactive Insulin CFP
    Starch-Dye Bound Polymer, Amylase CIW
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    System, Test, Immunological, Antigen, Tumor MOI
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    System, Test, Carcinoembryonic Antigen DHX
    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects LOK
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Haptoglobin, Antigen, Antiserum, Control DAD
    Calibrator, Multi-Analyte Mixture JIX
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    System, Test, Rheumatoid Factor DHR
    Acid, Uric, Uricase (Colorimetric) KNK
    Electrocautery, Gynecologic (And Accessories) HGI
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ

    Proprietary Names

    Twinfix Ti Suture Anchor ASPARTATE AMINOTRANSFERASE REAGENT Access Folate Assay Access Cortisol ACCESS HYBRITECH P2PSA AUTOSUTURE CLOSURE DEVICE ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems FIRSTPASS NEEDLE Fastener, Fixation, Nondegradable, Soft Tissue Q-FIX ALL-SUTURE ANCHOR CIBA CORNING ACS T3 IMMUNOASSAY VersaOne Bladed Trocar ACCESS ESTRADIOL REAGENTS Endo clinch UNSATURATED IRON BINDING CAPCITY REAGENT BNP TEST IMMUNOASSAY SYSTEMS HLH HUMAN LUTENIZING HORMONE OLYMPUS LIPASE REAGENT ACCESS PROLACTIN ASSAY Screw, fixation, bone Radioassay, vitamin b12 CIBA CORNING ACS TSH IMMUNOASSAY Access Ferritin Access Thyroglobulin Antibody ACCESS PROGESTERONE ASSAY Auto suture stapler OLYMPUS TRIGLYCERIDE TEST SYSTEM CALCIUM ARSENAZO REAGENT Urine/CSF Albumin, Urine/CSF Albumin Calibrator lenses, soft contact, daily wear Suture Anchor; Instrument, Ultrasonic Surgical (HARMONIC ACE + LAPAROSCOPIC SHEARS) FREE T3 CALIBRATORS IGA REAGENT ADVIA CENTAUR ANTI THYROGLOBULIN IMMUNOASSAYS Washer, Bolt Nut DIRECT BILIRUBIN REAGENT ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS ACCESS INTACT PTH AND CALIBRATORS Enzymatic Esterase--oxidase, Cholesterol Dyonics 25 Tube Set Access Free T4 ACS FRT4 IMMUNOASSAY Access Substrate CHIRON DIAGNOSTICS ACS: 180 FT3 COBLATION WAND SUPER TURBOVAC Biuret (colorimetric), Total Protein ULTRABUTTON Adjustable Fixation Device GLUCOSE REAGENT ISE Reagent, Glucose, CRP Latex Access Testosterone UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS TOTAL PROTEIN VERSAPORT OLYMPUS ALKALINE PHOSPHATASE REAGENT Access Vitamin B12 IGM REAGENT Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immunoassay System. (P/N: B24839 MN MFG); Access 25(O ALBUMIN REAGENT ACCESS DHEA-S REAGENT ASSAY BUN REAGENT SUTUREFIX ULTRA ANCHOR ACCESS ULTRASENSITIVE INSULIN ASSAY VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS AMYLASE REAGENT BLADELESS TROCAR ULTRABRAID SUTURE Access BR Monitor ACS: 180 AND ADVIA CENTAUR ANTITHYROGLOBULIN IMMUNOASSAY PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS VERSAPORT TROCAR ENDOBUTTON CL ULTRA FIXATION IGG REAGENT FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT SYMBOTEX COMPOSITE MESH VIDAS PRG HDL CHOLESTEROL (HDLX) ASSAY ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY Access CEA ACCESS AFP REAGENTS OLYMPUS TOTAL BILIRUBIN REAGENT ALANINE AMINOTRANSFERASE REAGENT IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT Jagwire RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT OLYMPUS MAGNESIUM REAGENT Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use OLYMPUS CREATININE REAGENT PROGRIP RIGHT ANATOMICAL URIC ACID REAGENT Radioimmunoassay, Free Thyroxine ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility