Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011989923

FEI Number

3011989923

Entity Name

DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI

City/State/Country

Istanbul, TR

Establishment Address

Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler, Istanbul 34235, TR

Establishment Type(s)

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

Owner / Operator

Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti (Owner Number: 10060275)

Owner / Operator Contact Address

Oruc Reis Mahallesi, Giyimkent 3 Sokak No 21A-23A Esenler, Istanbul, TR-34 34235, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K073490

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-07
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2025-01-15
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2024-11-08
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2024-11-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-11-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-09-22
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-02-06
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-02-06
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2023-01-20
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2025-01-15
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2025-01-15
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-12-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-04-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-09-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-05-28
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-09-20
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2023-01-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-29
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2024-11-08
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-11-08
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2025-12-08
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2025-01-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-07-02
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2025-05-21
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2025-01-15
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2024-11-08
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2024-11-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-10-13
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-04-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-07-02
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2020-07-02
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-04-23
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2023-01-20
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2023-01-20
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2024-11-08
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-11-20
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2024-11-08
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-11-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-06-18
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-06-18
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2024-11-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-02-04
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2025-01-15
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2025-05-08
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-05-08
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-01-08
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-01-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-12-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-11-23
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-07-07
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2025-07-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-02
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-01-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-08-05
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2025-01-15
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2023-01-20
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2019-09-20
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2025-02-06
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-02-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-23
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2026-02-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-11-07
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-11-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-01-20
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2023-01-20
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-11-20
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2023-01-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-09-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-05-28
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2026-02-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-09-28
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-01-15
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2025-05-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2025-05-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2025-05-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-05-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-05-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2025-05-30
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2024-11-08
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2025-01-15
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2025-01-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-01-15
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2025-01-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2025-01-15
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2025-01-15
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2025-01-15
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2025-01-15
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2025-01-15
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2025-01-15
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2025-01-15
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2025-01-15
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-01-15
LFP	Conductivity Rate, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2025-01-15
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2025-01-15
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2025-01-15
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2025-01-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-04-10
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2024-11-08
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2024-11-08
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2025-07-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-04-10
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2026-04-10
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2025-01-15
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2024-11-08
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2025-01-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-09-21
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2026-02-02
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2025-02-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-11-08
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2025-12-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-09-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-09-28
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2024-11-08
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2024-11-08
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2023-01-20
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-11-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-12-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-12-20
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2025-07-07

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2015	ELITech Clinical Systems SAS Zone lndustrielle SEES France	2	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Z-0032-2026	Beckman Coulter Inc.	2	DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011989923. Last updated year: 2026. Please use registration number 3011989923 when referencing this establishment in official correspondence.